Delivery Room CPAP in Extremely Low Birth Weight Infants

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Bronchopulmonary dysplasia
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Brief Title

Delivery Room CPAP in Extremely Low Birth Weight Infants

Official Title

Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (ELBW) Infants

Brief Summary

      This pilot study was designed to determine the feasibility of randomizing extremely low birth
      weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two
      resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway
      pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure
      (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP
      and no PEEP if the infant required PPV (the control group).

Detailed Description

      Previous studies suggested that early continuous airway positive pressure (CPAP) may be
      beneficial in reducing ventilator dependence and subsequent bronchopulmonary dysplasia (BPD)
      in extremely low birth weight (ELBW) infants. These studies did not test for the optimal
      timing of CPAP initiation or compare CPAP/PEEP initiation in the delivery room against
      standard resuscitation methods. Current practice at the time was for the ELBW infant to be
      intubated early and administered prophylactic surfactant. The feasibility of initiating CPAP
      in the DR and continuing this therapy without intubation for surfactant had not been
      determined prospectively in a population of ELBW infants.

      This pilot study was designed to determine the feasibility of randomizing extremely low birth
      weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two
      resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway
      pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure
      (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP
      and no PEEP if the infant required PPV (the control group).

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Compliance with the study protocol

Secondary Outcome

 Extent of resuscitation needed

Condition

Infant, Newborn

Intervention

CPAP/PEEP

Study Arms / Comparison Groups

 CPAP/PEEP Intervention
Description:  Infants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

104

Start Date

July 2002

Completion Date

January 2003

Primary Completion Date

January 2003

Eligibility Criteria

        Inclusion Criteria:

          -  Infants delivered in a specially equipped resuscitation room(s)

          -  <28 weeks gestational age by best obstetric estimate before delivery

          -  Requiring resuscitation

        Exclusion Criteria:

          -  No known major congenital anomalies

          -  Decision made not to provide full resuscitation

Gender

All

Ages

N/A - 10 Minutes

Accepts Healthy Volunteers

No

Contacts

Neil N. Finer, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01223274

Organization ID

NICHD-NRN-0028

Secondary IDs

U10HD021364

Study Sponsor

NICHD Neonatal Research Network

Collaborators

 National Center for Research Resources (NCRR)

Study Sponsor

Neil N. Finer, MD, Study Director, University of California, San Diego

Verification Date

September 2017