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Comparing Bubble and Ventilator Nasal CPAP in Preterm Infants

NCT ID: NCT02003846

Last Updated: 2015-06-30

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

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-10-31

Brief Summary

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There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal intensive care units (NICU) use an underwater bubbling system and others use a ventilator to generate the pressure. There is no right or wrong way to generate the pressure and both methods are approved and accepted.

The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each for a defined time period and reviewing the infant's vital signs. The investigators expect that the pressure generated by bubble CPAP will be better and lead to improved vital signs.

Detailed Description

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There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal intensive care units (NICU) use an underwater bubbling system and others use a ventilator to generate the pressure. There is no right or wrong way to generate the pressure and both methods are approved and accepted.

The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each for a defined time period and reviewing the infant's vital signs. The investigators expect that the pressure generated by bubble CPAP will be better and lead to improved vital signs.

Conditions

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Respiratory Distress Syndrome

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Premature infant

Each premature infant will be on bubble nasal CPAP for 2 hours and on ventilator nasal CPAP for 2 hours

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Neonates between 26-32 weeks gestational age who have been on Nasal CPAP for at least 48hrs on fraction of inspired oxygen (FiO2) of \< or = 0.3. Parental consent will be obtained prior to enrollment.

Exclusion Criteria

* Infants with severe congenital anomalies, such as airway or chest wall deformities, pulmonary hypoplasia, congenital heart disease, neurologic abnormalities including severe intraventricular hemorrhage (IVH) and need for surgery eg. for necrotizing enterocolitis will be excluded from the study. Any infants with genetic/chromosomal abnormalities will be excluded.
Minimum Eligible Age

2 Days

Maximum Eligible Age

3 Months

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

Attending Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shantanu Rastogi, 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

References

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Gregory GA, Kitterman JA, Phibbs RH, Tooley WH, Hamilton WK. Treatment of the idiopathic respiratory-distress syndrome with continuous positive airway pressure. N Engl J Med. 1971 Jun 17;284(24):1333-40. doi: 10.1056/NEJM197106172842401. No abstract available.

Reference Type BACKGROUND
PMID: 4930602 (View on PubMed)

Lee KS, Dunn MS, Fenwick M, Shennan AT. A comparison of underwater bubble continuous positive airway pressure with ventilator-derived continuous positive airway pressure in premature neonates ready for extubation. Biol Neonate. 1998;73(2):69-75. doi: 10.1159/000013962.

Reference Type BACKGROUND
PMID: 9483299 (View on PubMed)

Other Identifiers

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MMC 2013-02-10

Identifier Type: OTHER

Identifier Source: secondary_id

MMC 2013-02-10

Identifier Type: -

Identifier Source: org_study_id