Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome

NCT00780624 | Completed DMC

• 1 other identifier: NCR2008053
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome.

Conditions

Respiratory Distress Syndrome

Keywords

RDS; Infant, newborn; NIPPV; CPAP

Outcome Measures

Primary Outcomes (1)

• Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support.

  At 7 days after non-invasive respiratorynsupport.

Secondary Outcomes (1)

• Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age.

  At 7 days, 28 days and at 36 weeks postmenstraul age

Study Arms (2)

NIPPV

ACTIVE COMPARATOR

The NIPPV group receiving NIPPV treatment.

Device: NIPPV

Control

ACTIVE COMPARATOR

The Control group receiving nCPAP treatment.

Device: NIPPV

Interventions

NIPPV DEVICE

Ventilator is Bird VIP.

Control; NIPPV

Eligibility Criteria

• Age: 1 Minute - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn infants with birth weight \>500 gm.
• Gestational age \>24 completed weeks.
• Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: 1) the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support; 2)the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
• No known lethal congenital anomaly or genetic syndromes.
• Signed parental informed consent.

You may not qualify if:

• Considered non-viable by clinician (decision not to administer effective therapies)
• Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
• Infants known to require surgical treatment
• Abnormalities of the upper and lower airways
• Neuromuscular disorders
• Infants who are \>28 days old and continue to require mechanical ventilation with an endotracheal tube

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Related Publications (1)

• Shi Y, Tang S, Zhao J, Shen J. A prospective, randomized, controlled study of NIPPV versus nCPAP in preterm and term infants with respiratory distress syndrome. Pediatr Pulmonol. 2014 Jul;49(7):673-8. doi: 10.1002/ppul.22883. Epub 2013 Sep 4.

  PMID: 24039148 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Yuan Shi, MD

  Department of Pediatrics, Daping Hospital, Third Military Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief of Pediatrics

Study Record Dates

• First Submitted: October 24, 2008
• First Posted: October 27, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

CN (1)