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NCT Number: NCT02126501

Comparing Weaning of Nasal Continuous Positive Airway Pressure (CPAP) From Preterm Infants

To compare the 2 methods of weaning of nasal continuous positive airway pressure (CPAP) in premature babies born between 26 and 32 weeks

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Key information

Conditions

Respiratory Distress Syndrome Female Urogenital Diseases and Pregnancy Complications Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Tract Diseases Urogenital Diseases

Age range

26 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maimonides medcial center

Brooklyn, New York, 11219, United States

About this study

To study the weight and the post menstrual age (PMA) at the time of 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 between 26 and 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 neonates born 26 to 32 weeks of gestational age

Exclusion criteria

  • Those with severe congenital anomalies and chromosomal defects including congenital heart disease, neurological malformations, chest and airway abnormalities and lung hypoplasia

Treatment and study plan

Gradual pressure wean

Other

NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided

Primary outcomes

  1. Success of weaning on first trial off NCPAP

    Time frame: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks

Secondary outcomes

  1. Weight and corrected GA when come off oxygen

    Time frame: when off supplemental oxygen expected average of 2 weeks

  2. Weight and corrected gestational age (GA) when neonates could come off NCPAP

    Time frame: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks

Other outcomes

  1. length of stay in the neonatal intensive care unit

    Time frame: when ready to be discharged, expected average of 6-8 weeks

Sponsors and collaborators

Lead sponsor

Maimonides Medical Center

Other

Registry information

Official study title

Randomized Control Trial of Weaning NCPAP From Preterm Infants: Sudden Wean Versus Weaning by Gradually Decreasing Pressure

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 30, 2014
Registry last updated
Jun 8, 2016

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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