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Completed

NCT Number: NCT01215591

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

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

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Key information

Conditions

Preterm Neonates

Age range

24 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gradual weaning from Nasal CPAP in preterm neonates

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.

Other names: Nasal CPAP, Weaning, Preterm neonates

Primary outcomes

  1. Weight when preterm neonates could come off nasal CPAP

    Time frame: During the initial NICU stay

    Weight when preterm neonates could come off nasal CPAP

  2. Post-menstrual age when preterm neonates could come off nasal CPAP

    Time frame: During the initial NICU stay

    Post-menstrual age when preterm neonates could come off nasal CPAP

Secondary outcomes

  1. Weights when the neonates could come off oxygen

    Time frame: During the initial NICU stay

    Weights when the neonates could come off oxygen

  2. length of stay in the hospital

    Time frame: During the initial NICU stay

    length of stay in the hospital

  3. Post-menstrual age when preterm neonates could come off oxygen

    Time frame: During the initial NICU stay

    Post-menstrual age when preterm neonates could come off oxygen

Sponsors and collaborators

Lead sponsor

Maimonides Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 6, 2010
Registry last updated
Oct 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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