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

Maimonides Medical Center

Status: Completed

Conditions: Preterm Neonates

Treatments: Procedure: Gradual weaning from Nasal CPAP in preterm neonates

Study type: Interventional

Funder types: Other

Identifiers

NCT01215591

Maimonides Project 07/10/VA5

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 24 to 32 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

56 participants in 2 patient groups

Gradual wean from Nasal CPAP

Active Comparator group

Description:

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.

Treatment:

Procedure: Gradual weaning from Nasal CPAP in preterm neonates

Sudden wean from Nasal CPAP

No Intervention group

Description:

Usual practice to wean the preterm neonates from nasal CPAP