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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome
• Interventions: Device: NIPPV

• Registration Number: NCT00780624
• Lead Sponsor: Third Military Medical University

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.

Detailed Description

Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy. Nevertheless, NIPPV has never been used in chinese babies.

The submitted trial is the first prospective, randomized trial Comparing NIPPV vs nCPAP in newborn infants with respiratory distress syndrome.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-10-24
• Study First Submitted QC: 2008-10-24
• Study First Posted: 2008-10-27
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Newborn infants with birth weight >500 gm.
2. Gestational age >24 completed weeks.
3. 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.
4. No known lethal congenital anomaly or genetic syndromes.
5. Signed parental informed consent.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIPPV	NIPPV	The NIPPV group receiving NIPPV treatment.
Control	NIPPV	The Control group receiving nCPAP treatment.

Primary Outcome Measures

Name	Time	Method
Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support.	At 7 days after non-invasive respiratorynsupport.

Secondary Outcome Measures

Name	Time	Method
Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age.	At 7 days, 28 days and at 36 weeks postmenstraul age

Trial Locations

Locations (1)

Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China