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CompletedNCT01215591Updated Oct 24, 2012

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

An interventional study of Gradual weaning from Nasal CPAP in preterm neonates in Preterm Neonates, sponsored by Maimonides Medical Center. Completed at 1 site in United States. Open to participants aged 24 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2012-10-24.

Sponsored by Maimonides Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
24 Weeks to 32 Weeks
Sex
All
01

Study summary

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

Read the detailed 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.

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Conditions studied

  • Preterm Neonates

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Keywords

  • Neonatal
  • Nasal CPAP
  • Randomized controlled trial
  • Weaning
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 56 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Maimonides Medical Center is the lead sponsor of 50 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
24 Weeks to 32 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

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

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

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Active comparator
    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.

    Procedure: Gradual weaning from Nasal CPAP in preterm neonates

  • No intervention
    Sudden wean from Nasal CPAP

    Usual practice to wean the preterm neonates from nasal CPAP

Interventions

  • ProcedureGradual 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.

    Also known as: Nasal CPAP, Weaning, Preterm neonates

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What researchers measure

Primary outcomes

  1. Weight when preterm neonates could come off nasal CPAP

    Weight when preterm neonates could come off nasal CPAP

    Time frame: During the initial NICU stay

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

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

    Time frame: During the initial NICU stay

Secondary outcomes

  1. Weights when the neonates could come off oxygen

    Weights when the neonates could come off oxygen

    Time frame: During the initial NICU stay

  2. length of stay in the hospital

    length of stay in the hospital

    Time frame: During the initial NICU stay

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

    Post-menstrual age when preterm neonates could come off oxygen

    Time frame: During the initial NICU stay

07

Study locations

1 site
  • Maimonides Medical Center
    Brooklyn, New York 11219, United States
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References and documents

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01215591
Lead sponsor
Maimonides Medical Center
Responsible party
Shantanu Rastogi (Neonatologist, Maimonides Medical Center) — Principal investigator
First posted
Oct 6, 2010
Start date
Jan 2008
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Oct 24, 2012

Study contacts

Shantanu Rastogi, MD
principal investigator · Maimonides Medical Center
Alok Bhutada, MD
principal investigator · Maimonides Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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