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Nasal Intermittent Positive Pressure Ventilation(NIPPV) vs Continuous Positive Airway Pressure for Respiratory Distress Syndrome

Primary Purpose

Nasal Intermittent Positive Pressure Ventilation, Nasal Continuous Positive Airway Pressure

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NIPPV
NCPAP
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Intermittent Positive Pressure Ventilation

Eligibility Criteria

5 Minutes - 6 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gestational age (GA) is from 26 to 37 weeks;
  • Diagnosis of RDS. The diagnosis of respiratory distress syndrome(RDS) will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
  • RDS Silverman score>5;
  • Informed parental consent has been obtained.

Exclusion Criteria:

  • Severe RDS requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation;
  • Major congenital malformations or complex congenital heart disease;
  • Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
  • Cardiopulmonary arrest needing prolonged resuscitation;
  • Transferred out of the neonatal intensive care unit without treatment.

Sites / Locations

  • Department of Pediatrics, Daping Hospital, Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NIPPV

NCPAP

Arm Description

NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome

NCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome

Outcomes

Primary Outcome Measures

intubation rate
the infant is intubated ventilation

Secondary Outcome Measures

Intraventricular hemorrhage
the incidence of intraventricular hemorrhage
bronchopulmonary dysplasia
bronchopulmonary dysplasia was defined according to the National Institutes of Health consensus definition
Bayley Scales of Infant Development
scores of Bayley Scales of Infant Development
Neonatal necrotizing enterocolitis(NEC)
the incidence of neonatal necrotizing enterocolitis(>stage II);for NEC, Bell staging will be used

Full Information

First Posted
July 12, 2017
Last Updated
July 21, 2017
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Collaborators
Guiyang Maternity and Child Health Care Hospital, Children's Hospital of Chongqing Medical University, Chongqing Maternal and Child Health Hospital, Yan'an Affiliated Hospital of Kunming Medical University, The Children's Hospital of Zhejiang University School of Medicine, Chengdu Women's and Children's Central Hospital, Kunming Children's Hospital, Shanxi Provincial Maternity and Children's Hospital, Children's Hospital of Fudan University, Guangdong Women and Children Hospital, Nanjing Children's Hospital, Jiulongpo No.1 People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03226977
Brief Title
Nasal Intermittent Positive Pressure Ventilation(NIPPV) vs Continuous Positive Airway Pressure for Respiratory Distress Syndrome
Official Title
Nasal Intermittent Positive Pressure Ventilation vs Continuous Positive Airway Pressure for Preterm Infants With Respiratory Distress Syndrome:a Multicenter Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Anticipated)
Primary Completion Date
July 30, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Collaborators
Guiyang Maternity and Child Health Care Hospital, Children's Hospital of Chongqing Medical University, Chongqing Maternal and Child Health Hospital, Yan'an Affiliated Hospital of Kunming Medical University, The Children's Hospital of Zhejiang University School of Medicine, Chengdu Women's and Children's Central Hospital, Kunming Children's Hospital, Shanxi Provincial Maternity and Children's Hospital, Children's Hospital of Fudan University, Guangdong Women and Children Hospital, Nanjing Children's Hospital, Jiulongpo No.1 People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In the past, several studies have compared the effects between nasal intermittent positive pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the incidence of intubation in preterm infants, and the results were inconsistent.The purpose of the present study was to compare NIPPV with NCPAP on the need for endotracheal ventilation and subsequent complications
Detailed Description
To this day, early use of noninvasive respiratory support strategies has been suggested to be the most effective pathway to reduce those risks. Nasal continuous positive airway pressure (NCPAP) and nasal intermittent positive pressure ventilation (NIPPV) are two widely used ways of noninvasive ventilation strategies in preterm infant. As compared with invasive ventilation, NCPAP reduces the risks abnormal neurodevelopment. However, there is only 60% success rate of avoiding intubation in the preterm neonate supported with NCPAP. Supplying with an intermittent peak pressure on NCPAP, NIPPV is considered as a strengthened version of NCPAP with increased flow delivery in the upper airway, increased minute volume and functional residual capacity and recruitment of collapsed alveoli, improved stability of the chest wall and reduced asynchrony of thoraco-abdominal movement,which have been proven to be crucial to decrease the incidences of invasive ventilation and death. However, studies have compared the effects between nasal intermittent positive pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the incidence of intubation in preterm infants, and the results were inconsistent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Intermittent Positive Pressure Ventilation, Nasal Continuous Positive Airway Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIPPV
Arm Type
Experimental
Arm Description
NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome
Arm Title
NCPAP
Arm Type
Active Comparator
Arm Description
NCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome
Intervention Type
Device
Intervention Name(s)
NIPPV
Intervention Description
NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome
Intervention Type
Device
Intervention Name(s)
NCPAP
Intervention Description
NCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome
Primary Outcome Measure Information:
Title
intubation rate
Description
the infant is intubated ventilation
Time Frame
within 7 days
Secondary Outcome Measure Information:
Title
Intraventricular hemorrhage
Description
the incidence of intraventricular hemorrhage
Time Frame
within 28 days
Title
bronchopulmonary dysplasia
Description
bronchopulmonary dysplasia was defined according to the National Institutes of Health consensus definition
Time Frame
at a post-menstrual age of 36 weeks or at discharge
Title
Bayley Scales of Infant Development
Description
scores of Bayley Scales of Infant Development
Time Frame
at 2 months old and 2 years old
Title
Neonatal necrotizing enterocolitis(NEC)
Description
the incidence of neonatal necrotizing enterocolitis(>stage II);for NEC, Bell staging will be used
Time Frame
within 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Minutes
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age (GA) is from 26 to 37 weeks; Diagnosis of RDS. The diagnosis of respiratory distress syndrome(RDS) will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings; RDS Silverman score>5; Informed parental consent has been obtained. Exclusion Criteria: Severe RDS requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation; Major congenital malformations or complex congenital heart disease; Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage; Cardiopulmonary arrest needing prolonged resuscitation; Transferred out of the neonatal intensive care unit without treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ma Juan, MD
Phone
13508300283
Email
476679422@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi Yuan, PhD,MD
Organizational Affiliation
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Pediatrics, Daping Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Ma, physician
Phone
18680887330
Email
zoe330@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Nasal Intermittent Positive Pressure Ventilation(NIPPV) vs Continuous Positive Airway Pressure for Respiratory Distress Syndrome

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