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

NCT ID: NCT01215591

Last Updated: 2012-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Preterm Neonates

Keywords

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Neonatal Nasal CPAP Randomized controlled trial Weaning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gradual wean from Nasal CPAP

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.

Group Type ACTIVE_COMPARATOR

Gradual weaning from Nasal CPAP in preterm neonates

Intervention Type PROCEDURE

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.

Sudden wean from Nasal CPAP

Usual practice to wean the preterm neonates from nasal CPAP

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Nasal CPAP Weaning Preterm neonates

Eligibility Criteria

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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
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maimonides Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shantanu Rastogi

Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shantanu Rastogi, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Alok Bhutada, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

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Maimonides Medical Center

Brooklyn, New York, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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Maimonides Project 07/10/VA5

Identifier Type: -

Identifier Source: org_study_id