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Delivery Room CPAP in Extremely Low Birth Weight Infants (DR-CPAP)

Primary Purpose

Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CPAP/PEEP
Standard management practices
Sponsored by
NICHD Neonatal Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Newborn focused on measuring NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity, Mechanical ventilation, Positive-Pressure Ventilation, Surfactant, Intubation, Pulse oximetry, Oxygen saturation

Eligibility Criteria

undefined - 10 Minutes (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • University of California at San Diego
  • University of Miami
  • RTI International
  • Cincinnati Children's Medical Center
  • Case Western Reserve University, Rainbow Babies and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CPAP/PEEP Intervention

Control

Arm 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.

Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.

Outcomes

Primary Outcome Measures

Compliance with the study protocol

Secondary Outcome Measures

Extent of resuscitation needed
Five minute Apgar
Total duration of mechanical ventilation
Proportion of infants requiring surfactant
Bronchopulmonary dysplasia (BPD)
Number and duration of intubation attempts
Infants who required positive pressure ventilation for resuscitation in the DR/resuscitation room

Full Information

First Posted
October 14, 2010
Last Updated
September 22, 2017
Sponsor
NICHD Neonatal Research Network
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT01223274
Brief Title
Delivery Room CPAP in Extremely Low Birth Weight Infants
Acronym
DR-CPAP
Official Title
Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (ELBW) Infants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
NICHD Neonatal Research Network
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia, Continuous Positive Airway Pressure
Keywords
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity, Mechanical ventilation, Positive-Pressure Ventilation, Surfactant, Intubation, Pulse oximetry, Oxygen saturation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP/PEEP Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.
Intervention Type
Device
Intervention Name(s)
CPAP/PEEP
Other Intervention Name(s)
Neopuff
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.
Intervention Type
Device
Intervention Name(s)
Standard management practices
Intervention Description
Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.
Primary Outcome Measure Information:
Title
Compliance with the study protocol
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Extent of resuscitation needed
Time Frame
Until admission to NICU
Title
Five minute Apgar
Time Frame
5 minutes after birth
Title
Total duration of mechanical ventilation
Time Frame
Until hospital discharge or 120 days of life
Title
Proportion of infants requiring surfactant
Time Frame
1 day of life
Title
Bronchopulmonary dysplasia (BPD)
Time Frame
36 weeks of life
Title
Number and duration of intubation attempts
Time Frame
Until admission to the NICU
Title
Infants who required positive pressure ventilation for resuscitation in the DR/resuscitation room
Time Frame
Until admission to the NICU

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Minutes
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil N. Finer, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Avroy A. Fanaroff, MD
Organizational Affiliation
Case Western Reserve University, Rainbow Babies & Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waldemar A. Carlo, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward F. Donovan, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles R. Bauer, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
W. Kenneth Poole, PhD
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of California at San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8774
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
RTI International
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Cincinnati Children's Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve University, Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15342835
Citation
Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics. 2004 Sep;114(3):651-7. doi: 10.1542/peds.2004-0394.
Results Reference
result
Links:
URL
http://neonatal.rti.org/
Description
NICHD Neonatal Research Network

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Delivery Room CPAP in Extremely Low Birth Weight Infants

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