A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure

NCT01318824 | Unknown Phase 3 DMC

• 1 other identifier: 2011002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To research the effect of Bi-Level Positive Airway Pressure (BiPAP) for neonatal respiratory failure.

Conditions

Neonatal Respiratory Failure

Keywords

Neonatal Respiratory Failure; Newborn Infant; BiPAP; NIPPV

Outcome Measures

Primary Outcomes (1)

• the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure

  get the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure

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

Secondary Outcomes (1)

• the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure

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

Study Arms (2)

I=NIPPV

PLACEBO COMPARATOR

This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.

Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)

II=BiPAP

EXPERIMENTAL

This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment

Procedure: Bi-Level Positive Airway Pressure (BIPAP)

Interventions

Nasal Intermittent Positive Pressure Ventilation (NIPPV) PROCEDURE

The Control group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment

Also known as: Nasal Intermittent Positive Pressure Ventilation

I=NIPPV

Bi-Level Positive Airway Pressure (BIPAP) PROCEDURE

BiPAP group receive Bi-Level Positive Airway Pressure (BIPAP) treatment

Also known as: Bi-Level Positive Airway Pressure

II=BiPAP

Eligibility Criteria

• Age: Up to 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: 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 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

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Study Officials

• Yuan Shi, MD

  Department of Pediatrics, Daping Hospital, Third Military Medical University

  STUDY DIRECTOR

• Shifang Tang

  Department of Pediatrics, Daping Hospital, Third Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: March 21, 2011
• Study Start: December 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2013
• Last Updated: March 23, 2011

Record last verified: 2011-01

Locations

CN (1)