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

NCT ID: NCT02126501

Last Updated: 2016-06-08

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Distress Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sudden wean

When ready Nasal Continuous Positive Airway Pressure (NCPAP) will be removed from the neonate

Group Type NO_INTERVENTION

No interventions assigned to this group

Gradual pressure wean

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

Group Type ACTIVE_COMPARATOR

Gradual pressure wean

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gradual pressure wean

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

26 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maimonides Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shantanu Rastogi, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maimonides medcial center

Brooklyn, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Amatya S, Macomber M, Bhutada A, Rastogi D, Rastogi S. Sudden versus gradual pressure wean from Nasal CPAP in preterm infants: a randomized controlled trial. J Perinatol. 2017 Jun;37(6):662-667. doi: 10.1038/jp.2017.10. Epub 2017 Feb 23.

Reference Type DERIVED
PMID: 28230835 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MMC 13/01/VA03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.