Delivery Room CPAP in Extremely Low Birth Weight Infants

NCT01223274 | Completed Phase 1 DMC

• 10 other identifiers: NICHD-NRN-0028U10HD021364M01RR000080U10HD034216U10HD027853M01RR008084U10HD021397M01RR016587U10HD040461U10HD036790
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 6

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Compliance with the study protocol

  6 months

Secondary Outcomes (7)

• Extent of resuscitation needed

  Until admission to NICU

• Five minute Apgar

  5 minutes after birth

• Total duration of mechanical ventilation

  Until hospital discharge or 120 days of life

• Proportion of infants requiring surfactant

  1 day of life

• Bronchopulmonary dysplasia (BPD)

  36 weeks of life

Study Arms (2)

CPAP/PEEP Intervention

EXPERIMENTAL

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.

Device: CPAP/PEEP

Control

ACTIVE COMPARATOR

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

Device: Standard management practices

Interventions

CPAP/PEEP DEVICE

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.

Also known as: Neopuff

CPAP/PEEP Intervention

Standard management practices DEVICE

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

Control

Eligibility Criteria

• Age: Up to 10 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants delivered in a specially equipped resuscitation room(s)
• \<28 weeks gestational age by best obstetric estimate before delivery
• Requiring resuscitation

You may not qualify if:

• No known major congenital anomalies
• Decision made not to provide full resuscitation

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California at San Diego

San Diego, California, 92103-8774, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 15342835 RESULT

Related Links

• NICHD Neonatal Research Network

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Neil N. Finer, MD

  University of California, San Diego

  STUDY DIRECTOR

• Avroy A. Fanaroff, MD

  Case Western Reserve University, Rainbow Babies & Children's Hospital

  PRINCIPAL INVESTIGATOR

• Waldemar A. Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Edward F. Donovan, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Charles R. Bauer, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• W. Kenneth Poole, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: July 1, 2002
• Primary Completion: January 1, 2003
• Study Completion: January 1, 2003
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

US (6)