search
Back to results

Lung UltrasouNd Guided Surfactant Therapy in Preterm Infants (LUNG Study) (LUNG)

Primary Purpose

Respiratory Distress Syndrome, Newborn

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lung ultrasound score (LUS)
Sponsored by
Azienda Ospedaliero-Universitaria Careggi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn

Eligibility Criteria

1 Minute - 3 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. In-born infants at 25+0-29+6 weeks of gestational age
  2. Spontaneously breathing at birth but requiring noninvasive respiratory support with nCPAP at a pressure of 6-8 cmH2O to maintain an SpO2 between 90% and 95%.
  3. Parental consent has been obtained
  4. Exclusion of causes of respiratory failure other than RDS

Exclusion Criteria:

  1. Endotracheal intubation in the delivery room for resuscitation or insufficient respiratory drive according to European guidelines
  2. Prolonged premature rupture of membranes (PROM) for more than 3 days
  3. Presence of major congenital malformations or chromosomal anomalies
  4. Hydrops fetalis
  5. Inherited disorders of metabolism
  6. Administration of surfactant before performing the LUS.
  7. Other respiratory diseases than RDS

Sites / Locations

  • Neonatal intensive care unit - Azienda Sanitaria dell'Alto AdigeRecruiting
  • Spedali Civili di BresciaRecruiting
  • AOU CareggiRecruiting
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, MilanoRecruiting
  • Neonatal Intensive Care Unit ModenaRecruiting
  • Azienda Ospedaliero-Universitaria PisanaRecruiting
  • Neonatologia e Terapia Intensiva Neonatale RiminiRecruiting
  • Fondazione Policlinico GemelliRecruiting
  • Azienda sanitaria universitaria Friuli CentraleRecruiting
  • Germans Trias i PujolRecruiting
  • Barcelona Center for Maternal Fetal and Neonatal MedicineRecruiting
  • Neonatal Intensive Care Unit, Puerta del Mar Universitary Hospital, Cádiz.Recruiting
  • Neonatal Intensive Care Unit CoruñaRecruiting
  • Hospital Gregorio MaranonRecruiting
  • Hospital Alvaro Cunqueiro de Vigo. Instituto de Investigación Galicia SurRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group (CG)

LUS group (LUSG)

Arm Description

decision to administer exogenous surfactant when FiO2 >0.30 on nCPAP (pressure 6-8 cmH20) to maintain preductal SpO2 between 90 and 95%.

decision to administer surfactant when LUS > 8 on nCPAP (pressure 6-8 cmH20) to maintain preductal SpO2 between 90 and 95%. The LUS group will receive surfactant administration as rescue therapy in case of LUS < or = 8 but FiO2 > 0.30 on nCPAP (pressure 6-8 cmH20) to maintain preductal SpO2 between 90 and 95%.

Outcomes

Primary Outcome Measures

BPD or Death reduction
Primary endpoint will be the difference in proportion of infants with BPD (defined as Bancalari, Jobe 2001) or death in the group managed with LUS compared to the control group.

Secondary Outcome Measures

Proportion of infants treated "early" (before 3 hours of life) vs late
Percent of infants treated within 3 hours of life vs late
Age in minute at the first surfactant administration
Minutes
Needs of mechanical ventilation in the first 3 days of life
Percent of infants needed mechanical ventilation within 3 days of life
Max FiO2 value before surfactant treatment
FiO2 value
FiO2/SpO2 ratio before surfactant treatment
FiO2/SpO2 ratio
Duration of non-invasive and invasive respiratory support (included O2 therapy)
Days
Proportion of infants needed to receive multiple doses of surfactant
Percentage
Duration of hospitalization
Days
Occurrence of BPD using multiple definitions
Proportion
Proportion of infants with patent ductus arteriosus treated pharmacologically and/or surgically
Percentage
Proportion of infants with pneumothorax
Percentage
Proportion of infants with retinopathy of prematurity
Percentage
Proportion of infants with intraventricular hemorrhage > or = grade 3
Percentage
Proportion of infants with periventricular leukomalacia
Percentage
Proportion of infants with necrotizing enterocolitis > stage 2
Percentage
Use of systemic postnatal steroids
Percentage
Mortality
Percentage
Pulmonary hemorrhage
Percentage

Full Information

First Posted
December 25, 2021
Last Updated
May 31, 2023
Sponsor
Azienda Ospedaliero-Universitaria Careggi
search

1. Study Identification

Unique Protocol Identification Number
NCT05198375
Brief Title
Lung UltrasouNd Guided Surfactant Therapy in Preterm Infants (LUNG Study)
Acronym
LUNG
Official Title
Lung UltrasouNd Guided Surfactant Therapy in Preterm Infants: an International Multicentric Randomized Control Trial (LUNG Study)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria Careggi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The investigators hypothesized that the use of lung ultrasound (LU) for measuring RDS severity and deciding surfactant treatment thresholds might decrease the incidence of early and late sequelae in the study group. Thus, a timely surfactant therapy would eventually improve short (e.g. Need of mechanical ventilation in the first 3 days) and more long-term outcomes, such as BPD or death. To confirm this hypothesis, the investigators planned an international multicenter randomized controlled study in which preterm infants will be randomized into two groups: one will be managed deciding surfactant treatment of preterm infants with RDS on the basis of a cut-off value of FiO2 as for European guidelines, and one will be managed deciding surfactant treatment using a LU score cut-off and/or FiO2. Primary endpoint will be the reduction in proportion of infants with BPD or death in the group managed with LU compared to the control group
Detailed Description
Background Management of neonatal respiratory distress syndrome (RDS) involves noninvasive respiratory supports, such as nasal continuous positive airway (nCPAP), and mechanical ventilation. On the other hand, exogenous surfactant administration is the other cornerstone for the treatment of RDS. Currently, the decision to administer surfactant in a non-invasively ventilated newborn is commonly based on cut-off values of inspired fraction of oxygen (FiO2). Nevertheless, the accuracy of this criterion might be weak because FiO2 values depend per se by the setting of respiratory support. Moreover, the American Academy of Pediatrics guidelines do not recommend any FiO2 threshold for surfactant administration. It has been shown that prompt administration of surfactant (within the first 3 hours of life) can reduce the risk of bronchopulmonary dysplasia (BPD). Unfortunately, criteria for surfactant treatment used, often leads to a delayed administration. The role of lung ultrasound (LU) as a semi-quantitative method for the decision to give exogenous surfactant has been studied in recent years. Researchers demonstrated that a LU score (LUS) of RDS severity is able to predict the need for surfactant therapy, as subsequently confirmed by subsequent studies. After these results, a first quality improvement study demonstrated that the use of a LUS cut-off for deciding surfactant treatment allowed a significant increase of early administration. This finding has been confirmed by a recent single-center randomized controlled trial. However, all these studies were single-center, and there are not multicenter randomized controlled trials which can support the wide use of LUS measurement as a standard method for surfactant replacement therapy. This study, in addition to investigating the decision-making role of LUS in the administration of surfactant, also aims to evaluate the possibility of making treatment with surfactant earlier and more timely, having already been shown in the past that an early administration improves clinical outcomes. Aim of the study The investigators hypothesized that the use of a LUS for measuring RDS severity and deciding surfactant treatment thresholds might decrease the incidence of early and late sequelae in the study group. Thus, a timely surfactant therapy would eventually improve short (e.g. Need of mechanical ventilation in the first 3 days) and more long-term outcomes, such as BPD or death. To confirm this hypothesis, the investigators planned an international multicenter randomized controlled study in which preterm infants will be randomized into two groups: one will be managed deciding surfactant treatment of preterm infants with RDS on the basis of a cut-off value of FiO2 (CG), and one will be managed deciding surfactant treatment using a LUS cut-off and FiO2 (LUSG). Study design The study will be a multicenter randomized open control trial carried out in Level III-IV neonatal intensive care units (NICUs). The financial outcome of the study is no profit. The design of the study is of superiority. The enrollment period will be 24 months (starting February 1, 2022). Study population The study will take place within the NICUs and therefore in a hospital setting. The study will be multicenter. The total number of enrolled infants will be 668 (334 per arm). Each center will have to enroll a minimum of 10 children and a maximum of 70. An interim analysis will be conducted after 167 infants enrolled in each arm (334 total infants enrolled). Management in the delivery room and in the first hour of life Positive pressure with a neonatal mask and a T-piece system (Neopuff Infant Resuscitator ®, Fisher and Paykel, Auckland, New Zealand) will be used to stabilize the newborns after birth as per routine daily practice. If necessary, infants will start mechanical ventilation in agreement with the European guidelines on neonatal resuscitation. In this latter case the babies will be excluded from the study (see Exclusion criteria section). In order to better standardize the timing of care after birth, it is expected that assistance in the delivery room, transfer of the newborn to the intensive care unit, stabilization of the newborn and the related procedures (positioning of the vascular access, stabilization of ventilatory parameters, thermal stabilization, etc.) are completed within the first hour of life. Once infants with RDS have been screened, enrolled in the study, and allocated to the CG or LUSG, LU will be performed as soon as possible between 1 and 3 hours life (<3 h of life). In the meantime, the newborns will be assisted in noninvasive ventilation (nCPAP, pressure 6-8 cmH20) and oxygen to maintain preductal oxygen saturation (SpO2) between 90 and 95%. A loading dose of caffeine citrate of 20 mg/kg will be administered in the first hours of life followed by a maintenance of 5 mg/kg/day, as per routine clinical practice. Noninvasive ventilation management after the first 3 hours of life or after surfactant administration After the first three hours of life or after having administered surfactant, according to the criteria provided by the randomization group, the newborns can be assisted with non-invasive ventilation other than nCPAP (NIPPV, BiPAP, HFNC) according to the care protocol of the centers involved in the study. Lung ultrasound procedure LU will be performed by the attending physician. Centers participating to the study should be routinely using LU and all the physician are already trained for the use of the technique. LUS will be calculated by performing longitudinal scans of the chest in the anterior (midclavicular line), lateral (anterior axillary line) and posterior (posterior axillary line) area bilaterally using high-frequency linear or micro linear (hockey stick) probe between 1 and 3 hour of life. The focus will be located at the level of the pleural line. A score from 0 to 3 will be assigned to each scan area based on the ultrasound detected pattern (in case of different score pattern in the same area the worst will be the one chosen). LU can be performed keeping the patient in the supine position without the need to rotate him as the posterior axillary line is accessible from the side of the newborn. Surfactant replacement therapy should be given if LUS is 9 or more in the babies recruited to the LUSG. The LUS group will receive as rescue therapy surfactant administration in case of LUS < or = 8 but FiO2> 0.30 on nCPAP (pressure 6-8 cmH20) to maintain preductal SpO2 between 90 and 95%. Surfactant treatment Once criteria for surfactant administration have been reached, surfactant (Curosurf ®, Chiesi, Parma, Italy) will be given (200 mg/kg) according to the InSURE (Intubate-SURfactant-Extubate), LISA (Less- Invasive-Surfactant-Administration) or IN-REC-SURE (INtubate-RECruit-SURfactant-Extubate) technique in both the groups as per the enrollment center protocol. Pharmacological premedication with fentanest and/or atropine will be allowed (as per center protocol) and recorded. After surfactant administration, the babies of both groups will be extubated if it has been performed the InSURE or IN-REC-SURE method within 30 min (if satisfactory respiratory drive is present) and will receive nCPAP (pressure 6-8 cmH2O) as per center protocol . Infants of both groups can receive a subsequent dose of surfactant (100 mg/kg of poractant alfa) using the same method if they meet the non-invasive ventilation failure criteria again during the following 12 to 24 h. nCPAP ventilation failure criteria In the NICU, nCPAP will be the standard method of noninvasive support in all infants recruited to this trial. nCPAP failure is defined if any of the following criteria are met: FiO2 ≥ 0.30 to maintain a SpO2> 90 for at least 30 min unless rapid clinical deterioration has occurred; respiratory acidosis defined as pCO2 > 65 mmHg (8.5 kPa) and pH <7.20 on an arterial or capillary blood gas sample; apnea defined as more than four episodes of apnea per hour or more than two episodes of apnea per hour when ventilation with bag and mask or Neopuff will be required. Mechanical ventilation should commence if the patient meets one of the following criteria after additional dose of surfactant: pCO2 > 65 mmHg and pH <7.20, or paO2 <50 mm Hg, or FiO2 >0.40 after surfactant administration or in case of apnea (> 4 episodes in 1 hour or > 2 episodes in 1 hour ventilation with bag and mask or Neopuff ), and should continue with the aim of maintaining a pCO2 of 55-65 mmHg and a SpO2 of 90-95%, using synchronized Mechanical Ventilation (MV), volume controlled MV, or high frequency ventilation. Patients will be extubated as per center protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
668 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group (CG)
Arm Type
Active Comparator
Arm Description
decision to administer exogenous surfactant when FiO2 >0.30 on nCPAP (pressure 6-8 cmH20) to maintain preductal SpO2 between 90 and 95%.
Arm Title
LUS group (LUSG)
Arm Type
Experimental
Arm Description
decision to administer surfactant when LUS > 8 on nCPAP (pressure 6-8 cmH20) to maintain preductal SpO2 between 90 and 95%. The LUS group will receive surfactant administration as rescue therapy in case of LUS < or = 8 but FiO2 > 0.30 on nCPAP (pressure 6-8 cmH20) to maintain preductal SpO2 between 90 and 95%.
Intervention Type
Diagnostic Test
Intervention Name(s)
Lung ultrasound score (LUS)
Intervention Description
LU score (LUS) will be performed between 1 and 3 hours of life. LUS will be calculated by performing longitudinal scans of the chest in the anterior (midclavicular line), lateral (anterior axillary line) and posterior (posterior axillary line) area bilaterally using high-frequency linear or micro linear (hockey stick) probe. A score from 0 to 3 will be assigned to each area based on the ultrasound detected pattern.
Primary Outcome Measure Information:
Title
BPD or Death reduction
Description
Primary endpoint will be the difference in proportion of infants with BPD (defined as Bancalari, Jobe 2001) or death in the group managed with LUS compared to the control group.
Time Frame
36 weeks of gestational age or at the moment of discharge
Secondary Outcome Measure Information:
Title
Proportion of infants treated "early" (before 3 hours of life) vs late
Description
Percent of infants treated within 3 hours of life vs late
Time Frame
First 3 hours of life
Title
Age in minute at the first surfactant administration
Description
Minutes
Time Frame
First 12 hours of life
Title
Needs of mechanical ventilation in the first 3 days of life
Description
Percent of infants needed mechanical ventilation within 3 days of life
Time Frame
First 3 days of life
Title
Max FiO2 value before surfactant treatment
Description
FiO2 value
Time Frame
First 12 hours of life
Title
FiO2/SpO2 ratio before surfactant treatment
Description
FiO2/SpO2 ratio
Time Frame
First 12 hours of life
Title
Duration of non-invasive and invasive respiratory support (included O2 therapy)
Description
Days
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Title
Proportion of infants needed to receive multiple doses of surfactant
Description
Percentage
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Title
Duration of hospitalization
Description
Days
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Title
Occurrence of BPD using multiple definitions
Description
Proportion
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Title
Proportion of infants with patent ductus arteriosus treated pharmacologically and/or surgically
Description
Percentage
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Title
Proportion of infants with pneumothorax
Description
Percentage
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Title
Proportion of infants with retinopathy of prematurity
Description
Percentage
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Title
Proportion of infants with intraventricular hemorrhage > or = grade 3
Description
Percentage
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Title
Proportion of infants with periventricular leukomalacia
Description
Percentage
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Title
Proportion of infants with necrotizing enterocolitis > stage 2
Description
Percentage
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Title
Use of systemic postnatal steroids
Description
Percentage
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Title
Mortality
Description
Percentage
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Title
Pulmonary hemorrhage
Description
Percentage
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
3 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In-born infants at 25+0-29+6 weeks of gestational age Spontaneously breathing at birth but requiring noninvasive respiratory support with nCPAP at a pressure of 6-8 cmH2O to maintain an SpO2 between 90% and 95%. Parental consent has been obtained Exclusion of causes of respiratory failure other than RDS Exclusion Criteria: Endotracheal intubation in the delivery room for resuscitation or insufficient respiratory drive according to European guidelines Prolonged premature rupture of membranes (PROM) for more than 3 days Presence of major congenital malformations or chromosomal anomalies Hydrops fetalis Inherited disorders of metabolism Administration of surfactant before performing the LUS. Other respiratory diseases than RDS
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iuri Corsini, MD
Phone
003903557946468
Email
corsiniiuri@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carlo Dani, Prof
Phone
003903557946468
Email
cdani@unifi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iuri Corsini, MD
Organizational Affiliation
Careggi University Hospital of Florence
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatal intensive care unit - Azienda Sanitaria dell'Alto Adige
City
Bolzano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Staffler
Email
alex.staffler@sabes.it
First Name & Middle Initial & Last Name & Degree
Luca Massenzi
Email
Luca.Massenzi@sabes.it
Facility Name
Spedali Civili di Brescia
City
Brescia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Maria Risso
Email
francesco.risso@asst-spedalicivili.it
First Name & Middle Initial & Last Name & Degree
Salvatore Aversa
Email
salvatore.aversa@asst-spedalicivili.it
First Name & Middle Initial & Last Name & Degree
Salvatore Aversa
Facility Name
AOU Careggi
City
Florence
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iuri Corsini, MD
Phone
00390557946468
Email
corsiniiuri@gmail.com
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Mosca
Email
fabio.mosca@unimi.it
First Name & Middle Initial & Last Name & Degree
Domenica Mercadante
Email
domenica.mrc@gmail.com
First Name & Middle Initial & Last Name & Degree
Domenica Mercadante
Facility Name
Neonatal Intensive Care Unit Modena
City
Modena
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Berardi
Email
alberto.berardi@unimore.it
First Name & Middle Initial & Last Name & Degree
Francesca Miselli
Email
miselli.fnc@gmail.com
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Filippi
Email
luca.filippi@unipi.it
Facility Name
Neonatologia e Terapia Intensiva Neonatale Rimini
City
Rimini
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gina Ancora
Email
gina.ancora@auslromagna.it
First Name & Middle Initial & Last Name & Degree
Francesca Piano
Email
fpiano@hotmail.com
Facility Name
Fondazione Policlinico Gemelli
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Vento, Prof
Email
giovanni.vento@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Alessandro Perri
Facility Name
Azienda sanitaria universitaria Friuli Centrale
City
Udine
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Pittini
Email
carla.pittini@asufc.sanita.fvg.it
First Name & Middle Initial & Last Name & Degree
Marilena Savoia
Facility Name
Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Rodriguez-Fanjul
Email
javierrodriguezfanjul@gmail.com
Facility Name
Barcelona Center for Maternal Fetal and Neonatal Medicine
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Aldecoa Bilbao
Email
valdecoa@clinic.cat
Facility Name
Neonatal Intensive Care Unit, Puerta del Mar Universitary Hospital, Cádiz.
City
Cadiz
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Almudena Ojembarrena
Email
almudena.alonso.sspa@juntadeandalucia.es
Facility Name
Neonatal Intensive Care Unit Coruña
City
Coruña
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Fuentes Carballal,
Email
jesus.fuentes.carballal@sergas.es
Facility Name
Hospital Gregorio Maranon
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Sanchez Luna
Email
msluna@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Rebeca Gregorio Hernandez
Facility Name
Hospital Alvaro Cunqueiro de Vigo. Instituto de Investigación Galicia Sur
City
Vigo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelino Prieto
Email
marcelinopumarada@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ana Concheiro

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30974433
Citation
Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
Results Reference
result
PubMed Identifier
23152207
Citation
Bahadue FL, Soll R. Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD001456. doi: 10.1002/14651858.CD001456.pub2.
Results Reference
result
PubMed Identifier
31079857
Citation
Raschetti R, Yousef N, Vigo G, Marseglia G, Centorrino R, Ben-Ammar R, Shankar-Aguilera S, De Luca D. Echography-Guided Surfactant Therapy to Improve Timeliness of Surfactant Replacement: A Quality Improvement Project. J Pediatr. 2019 Sep;212:137-143.e1. doi: 10.1016/j.jpeds.2019.04.020. Epub 2019 May 10.
Results Reference
result
PubMed Identifier
32710304
Citation
Rodriguez-Fanjul J, Jordan I, Balaguer M, Batista-Munoz A, Ramon M, Bobillo-Perez S. Early surfactant replacement guided by lung ultrasound in preterm newborns with RDS: the ULTRASURF randomised controlled trial. Eur J Pediatr. 2020 Dec;179(12):1913-1920. doi: 10.1007/s00431-020-03744-y. Epub 2020 Jul 24.
Results Reference
result
PubMed Identifier
26237465
Citation
Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3.
Results Reference
result
PubMed Identifier
30108142
Citation
De Martino L, Yousef N, Ben-Ammar R, Raimondi F, Shankar-Aguilera S, De Luca D. Lung Ultrasound Score Predicts Surfactant Need in Extremely Preterm Neonates. Pediatrics. 2018 Sep;142(3):e20180463. doi: 10.1542/peds.2018-0463. Epub 2018 Aug 14.
Results Reference
result
PubMed Identifier
28687343
Citation
De Luca D, van Kaam AH, Tingay DG, Courtney SE, Danhaive O, Carnielli VP, Zimmermann LJ, Kneyber MCJ, Tissieres P, Brierley J, Conti G, Pillow JJ, Rimensberger PC. The Montreux definition of neonatal ARDS: biological and clinical background behind the description of a new entity. Lancet Respir Med. 2017 Aug;5(8):657-666. doi: 10.1016/S2213-2600(17)30214-X. Epub 2017 Jul 4.
Results Reference
result
PubMed Identifier
11401896
Citation
Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.
Results Reference
result
PubMed Identifier
32339409
Citation
Corsini I, Parri N, Ficial B, Dani C. Lung ultrasound in the neonatal intensive care unit: Review of the literature and future perspectives. Pediatr Pulmonol. 2020 Jul;55(7):1550-1562. doi: 10.1002/ppul.24792. Epub 2020 Apr 27.
Results Reference
result
PubMed Identifier
33773829
Citation
Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24.
Results Reference
result
PubMed Identifier
34293317
Citation
Raimondi F, Migliaro F, Corsini I, Meneghin F, Pierri L, Salome S, Perri A, Aversa S, Nobile S, Lama S, Varano S, Savoia M, Gatto S, Leonardi V, Capasso L, Carnielli VP, Mosca F, Dani C, Vento G, Dolce P, Lista G. Neonatal Lung Ultrasound and Surfactant Administration: A Pragmatic, Multicenter Study. Chest. 2021 Dec;160(6):2178-2186. doi: 10.1016/j.chest.2021.06.076. Epub 2021 Jul 19.
Results Reference
result
PubMed Identifier
33688032
Citation
Raimondi F, Migliaro F, Corsini I, Meneghin F, Dolce P, Pierri L, Perri A, Aversa S, Nobile S, Lama S, Varano S, Savoia M, Gatto S, Leonardi V, Capasso L, Carnielli VP, Mosca F, Dani C, Vento G, Lista G. Lung Ultrasound Score Progress in Neonatal Respiratory Distress Syndrome. Pediatrics. 2021 Apr;147(4):e2020030528. doi: 10.1542/peds.2020-030528. Epub 2021 Mar 9.
Results Reference
result
PubMed Identifier
1388792
Citation
de Vries LS, Eken P, Dubowitz LM. The spectrum of leukomalacia using cranial ultrasound. Behav Brain Res. 1992 Jul 31;49(1):1-6. doi: 10.1016/s0166-4328(05)80189-5.
Results Reference
result
PubMed Identifier
16009843
Citation
International Committee for the Classification of Retinopathy of Prematurity. The International Classification of Retinopathy of Prematurity revisited. Arch Ophthalmol. 2005 Jul;123(7):991-9. doi: 10.1001/archopht.123.7.991.
Results Reference
result
PubMed Identifier
413500
Citation
Bell MJ, Ternberg JL, Feigin RD, Keating JP, Marshall R, Barton L, Brotherton T. Neonatal necrotizing enterocolitis. Therapeutic decisions based upon clinical staging. Ann Surg. 1978 Jan;187(1):1-7. doi: 10.1097/00000658-197801000-00001.
Results Reference
result

Learn more about this trial

Lung UltrasouNd Guided Surfactant Therapy in Preterm Infants (LUNG Study)

We'll reach out to this number within 24 hrs