Trial of Weaning of Nasal Continuous Positive Airway Pressure (CPAP)

Preterm Neonates Clinical Trial

Official title:

Randomized Controlled Trial of Gradual Versus Sudden Weaning From Nasal CPAP in Preterm Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215591
• Other study ID #: Maimonides Project 07/10/VA5
• Status: Completed
• Phase: N/A
• First received: September 27, 2010
• Last updated: October 22, 2012
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: October 2012
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To compare the 2 methods of weaning of nasal CPAP in premature babies born at 32 weeks or less

Description:

Objective: To study the weight and the post menstrual age (PMA) at the time of nasal CPAP (NCPAP) wean utilizing the method of sudden wean as compared to gradual wean. . Methods: A prospective randomized trial was conducted comparing sudden weaning with gradual weaning from NCPAP in neonates with gestational age (GA) <32 weeks. The patients were randomized to one of the two methods of weaning from NCPAP and their success was compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Weeks to 32 Weeks

Eligibility

Inclusion Criteria:

All babies born with GA <32 weeks admitted to the neonatal intensive care units at the Maimonides Infant and Children's Hospital, between 1st January 2008 and 31st March 2009 and required to be on NCPAP for longer than 48 hours.-

Exclusion Criteria:

Those with severe congenital anomalies and chromosomal defects including congenital heart disease and neurological malformations, chest wall or airway abnormalities and lung hypoplasia, were excluded from the cohort

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Preterm Neonates

Intervention

Procedure:
• Gradual weaning from Nasal CPAP in preterm neonates
Nasal CPAP for gradual wean group it was cycled off for 3 hours alternating with 3 hours on for first 48 hours, if successful the cycle was extended to 6 hours off and 3 hours on for the next 48 hours. If the baby tolerated this regime the prongs were removed and CPAP was kept off.

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight when preterm neonates could come off nasal CPAP	Weight when preterm neonates could come off nasal CPAP	During the initial NICU stay	No
Primary	Post-menstrual age when preterm neonates could come off nasal CPAP	Post-menstrual age when preterm neonates could come off nasal CPAP	During the initial NICU stay	No
Secondary	Weights when the neonates could come off oxygen	Weights when the neonates could come off oxygen	During the initial NICU stay	No
Secondary	length of stay in the hospital	length of stay in the hospital	During the initial NICU stay	No
Secondary	Post-menstrual age when preterm neonates could come off oxygen	Post-menstrual age when preterm neonates could come off oxygen	During the initial NICU stay	No

External Links

•   pubmed abstract