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Ventilatory Management of the Preterm Neonate in the Delivery Room

Primary Purpose

Respiratory Distress Syndrome, Newborn

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP
Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Distress Syndrome, Newborn focused on measuring Preterm, Neonates, Delivery room, Resuscitation, Ventilation, Neopuff, CPAP

Eligibility Criteria

27 Weeks - 33 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Preterm infants (gestational age < 34 weeks)

Exclusion Criteria:

  • 1. Neonates with major congenital anomalies (congenital heart disease, neural tube defect, trisomy, etc.).

    2.Meconium aspiration syndrome, congenital diaphragmatic hernia and anterior abdominal wall defect.

    3.Maternal chorioamnionitis. 4.Neonates with gestational age < 26 weeks and /or birth weight less than 750 grams.

Sites / Locations

  • Gynecology and Obstetrics hospital, Ain-Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sustained lung inflation followed by CPAP

Conventional self inflating bag and mask ventilation

Arm Description

Sustained pressure-controlled inflation using a neonatal mask and a T-piece ventilator (NeoPuff Infant Resuscitator; Fisher & Paykel, Auckland, New Zealand). This will be followed by early CPAP.

Intermittent bag and mask ventilation using a self-inflating bag with an oxygen reservoir.

Outcomes

Primary Outcome Measures

Proportionate of neonates in each group who will need endotracheal intubation after failure of positive pressure ventilation through face mask in the delivery room.
Need for mechanical ventilation for neonates on nCPAP

Secondary Outcome Measures

Occurrence and duration of oxygen therapy.
Bronchopulmonary dysplasia (BPD): defined as oxygen requirements more than 28 days.
Pulmonary air leaks
Patent ductus arteriosus (PDA).
Necrotizing enterocolitis (NEC).
Intraventricular hemorrhage (IVH).
Neonatal sepsis.
Length of NICU stay.
Delivery room death or death during admission.
Inflammatory mediators before and after resuscitation
Serum Interleukin-1β (IL-1β) and Tumor Necrosis Factor-α (TNF-α)will be measured both initial cord blood before any resuscitation is done and a second time two hours after resuscitation.

Full Information

First Posted
December 7, 2010
Last Updated
August 30, 2017
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT01255826
Brief Title
Ventilatory Management of the Preterm Neonate in the Delivery Room
Official Title
Ventilatory Management of the Preterm Neonate in the Delivery Room.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate sustained lung inflation followed by early nCPAP as delivery room ventilatory management for preterm neonates at risk of respiratory distress syndrome in reducing their need for mechanical ventilation and ameliorating lung injury without inducing adverse effects compared with intermittent bag and mask ventilation.
Detailed Description
Neonatal resuscitation provides lifesaving intervention that, if properly conducted, not only can reduce mortality but probably can significantly decrease subsequent morbidity. Premature infants need appropriate respiratory support and a lung-protective strategy, starting from the delivery room where, on the contrary, an inadequate respiratory approach may influence pulmonary outcome. Mechanical ventilation in the form of positive pressure ventilation has remained the mainstay of treatment of respiratory distress syndrome (RDS) in preterm babies. In recent years, a number of new ventilation strategies have been introduced but the problem of bronchopulmonary dysplasia (BPD) has not been solved. Sustained lung inflation (SLI) lead to a large increase in the tidal volume and the functional residual capacity(FCR) as this intervention may influence the clearance of lung fluids and allow a more even distribution of air throughout the lungs, thus facilitating the formation of FRC. Nasal CPAP and early PEEP act through stabilization and subsequent recruitment of collapsed alveoli, increased FRC resulting in increased alveolar surface area for gas exchange and a decrease in intrapulmonary shunt .also it conserves endogenous surfactant. Previous studies with promising results showed that a combination of sustained lung inflation and early nasal CPAP may be the most effective and least injurious way to recruit the lung in preterm neonates at birth. This study will evaluate sustained lung inflation followed by early nCPAP as delivery room ventilatory management for preterm neonates at risk of respiratory distress syndrome in reducing their need for mechanical ventilation and ameliorating lung injury without inducing adverse effects compared with intermittent bag and mask ventilation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn
Keywords
Preterm, Neonates, Delivery room, Resuscitation, Ventilation, Neopuff, CPAP

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sustained lung inflation followed by CPAP
Arm Type
Active Comparator
Arm Description
Sustained pressure-controlled inflation using a neonatal mask and a T-piece ventilator (NeoPuff Infant Resuscitator; Fisher & Paykel, Auckland, New Zealand). This will be followed by early CPAP.
Arm Title
Conventional self inflating bag and mask ventilation
Arm Type
Active Comparator
Arm Description
Intermittent bag and mask ventilation using a self-inflating bag with an oxygen reservoir.
Intervention Type
Procedure
Intervention Name(s)
Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP
Intervention Description
After oropharyngeal and nasal suctioning, if there are no signs of spontaneous breathing or breathing is insufficient and/or heart rate is below 100 bpm, the following approach will be followed:Pressure-controlled (20 cm H2O) inflation will be sustained for 15 secs, using a neonatal mask and a T-piece ventilator (NeoPuff Infant Resuscitator; Fisher & Paykel).To avoid pressure leakage, we will use a neonatal mask of appropriate size which adequately cover both the mouth and nostrils of infants. This pressure controlled inflation will be followed by CPAP at 5 Cm H2O.This procedure will be repeated a second time with a pressure of 25 cm H2O for 15 secs if breathing remained insufficient and/or the heart rate is < 100 bpm and/or the infant is cyanotic. To be followed by CPAP at 6 Cm H2O.A third puff with a pressure of 30 cm H2O for 15 secs will be used after few seconds if inadequate heart rate and respiration was not reached. This will be followed by CPAP at 7 Cm H2O.
Intervention Type
Procedure
Intervention Name(s)
Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.
Intervention Description
After oropharyngeal and nasal suctioning, if there is no signs of spontaneous breathing or breathing is insufficient and/or heart rate is below 100 bpm, intermittent mask and bag ventilation will be administrated at a rate 40-60 per minute using a self-inflating bag and mask with an oxygen reservoir.
Primary Outcome Measure Information:
Title
Proportionate of neonates in each group who will need endotracheal intubation after failure of positive pressure ventilation through face mask in the delivery room.
Time Frame
2 minutes
Title
Need for mechanical ventilation for neonates on nCPAP
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Occurrence and duration of oxygen therapy.
Time Frame
28 days
Title
Bronchopulmonary dysplasia (BPD): defined as oxygen requirements more than 28 days.
Time Frame
28 days
Title
Pulmonary air leaks
Time Frame
28 days
Title
Patent ductus arteriosus (PDA).
Time Frame
7 days
Title
Necrotizing enterocolitis (NEC).
Time Frame
28 days
Title
Intraventricular hemorrhage (IVH).
Time Frame
28 days
Title
Neonatal sepsis.
Time Frame
28 days
Title
Length of NICU stay.
Time Frame
28 days
Title
Delivery room death or death during admission.
Time Frame
28 days
Title
Inflammatory mediators before and after resuscitation
Description
Serum Interleukin-1β (IL-1β) and Tumor Necrosis Factor-α (TNF-α)will be measured both initial cord blood before any resuscitation is done and a second time two hours after resuscitation.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
27 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preterm infants (gestational age < 34 weeks) Exclusion Criteria: 1. Neonates with major congenital anomalies (congenital heart disease, neural tube defect, trisomy, etc.). 2.Meconium aspiration syndrome, congenital diaphragmatic hernia and anterior abdominal wall defect. 3.Maternal chorioamnionitis. 4.Neonates with gestational age < 26 weeks and /or birth weight less than 750 grams.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Sami El Shimi, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hesham Abdel Samie Awad, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarek Mohey El Gammacy, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ola Galal Badr El Deen, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dina Mohamed Mohamed Shinkar, MSc
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecology and Obstetrics hospital, Ain-Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Ventilatory Management of the Preterm Neonate in the Delivery Room

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