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

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780624
• Other study ID #: NCR2008053
• Status: Completed
• Phase: N/A
• First received: October 24, 2008
• Last updated: April 20, 2016
• Start date: January 2008
• Est. completion date: December 2012

Study information

• Verified date: April 2016
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Device:
• NIPPV
Ventilator is Bird VIP.
• NIPPV
Ventilator(Bird VIP) is used for NIPPV device. Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.
• NIPPV
Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group. The duration of NIPPV is according to the baby's respiratory condition.

Locations

Country	Name	City	State
China	Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support.		At 7 days after non-invasive respiratorynsupport.	No
Secondary	Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age.		At 7 days, 28 days and at 36 weeks postmenstraul age	No