Pilot Study to Assess Safety and Feasibility of Resuscitation of Preterm Infants With Controlled Volume of Air/Oxygen

This study has been terminated.
Sponsor:
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00157989
First received: September 8, 2005
Last updated: September 8, 2006
Last verified: September 2006
  Purpose

QUESTION:

Is controlled tidal volume delivery during the resuscitation of preterm infants < 28 weeks’ gestation safe and feasible?

BACKGROUND AND RATIONALE: Current resuscitation of preterm neonates follows the Neonatal Resuscitation Program (NRP) guidelines. During initial resuscitation, neonates are bagged with self/flow inflating bags to achieve adequate chest rise, heart rate > 100 per minute and a pink color. When positive pressure ventilation is delivered with a bag, tidal volume is not measured. It is likely that high tidal volume is delivered to the neonate in order to achieve a rapid response. The evidence from human and animal model studies suggests that the initiation of mechanical ventilation and volutrauma associated with continued ventilation, are associated with an increase in pro-inflammatory mediators in the lungs of the preterm infants which induce pulmonary injury. This may interfere with the signaling involved in alveolarization, leading to a decrease in alveolar formation or maldevelopment of the alveoli, and subsequent evolution to chronic lung disease (CLD) or bronchopulmonary dysplasia (BPD).

OBJECTIVE: To evaluate the safety and feasibility of controlling tidal volume delivery (and limiting manual ventilation), during the resuscitation of preterm infants < 28 weeks’ gestation.

STUDY DESIGN AND SETTING: A randomized controlled pilot study of 40 preterm neonates at the Mount Sinai Hospital.

RESEARCH PLAN: All eligible parents at risk for preterm delivery at < 28 weeks’ gestation will be approached. After obtaining written informed consent, infants will be randomized to standard resuscitation according to NRP guidelines (control group) or resuscitation using controlled tidal volume ventilation (5 ml/kg) (study group), if they require resuscitation. Crossover to the control group will be allowed if there is clinical deterioration or no clinical improvement after 3 minutes of intervention.

OUTCOMES:

  1. Primary: Apgar scores at 5,10, 15 and 20 minutes and pH, pO2, and pCO2 levels within 1 hour of resuscitation and at 4 hours of life.
  2. Secondary: Durations of mechanical ventilation, continuous positive airway pressure support, low flow oxygen/air requirement; respiratory status of infant at 28 days postnatal and 36 weeks’ corrected gestational age. Incidences of air leak, intraventricular haemorrhage and all causes of mortality before discharge from NICU will be compared.

Condition Intervention Phase
Resuscitation
Procedure: Controlled tidal volume resuscitation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Safety and Feasibility of Controlled Tidal Volume Resuscitation of Preterm Infants ≤ 28 Weeks’ Gestation: A Randomized Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Apgar scores at 5,10, 15 and 20 minutes and pH, pO2, and pCO2 levels within 1 hour of resuscitation and at 4 hours of life.

Secondary Outcome Measures:
  • Durations of mechanical ventilation, continuous positive airway pressure support, low flow oxygen/air requirement; respiratory status of infant at 28 days postnatal and 36 weeks’ corrected gestational age

Estimated Enrollment: 40
Study Start Date: October 2004
Estimated Study Completion Date: August 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 1 Hour
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All neonates born at <28 completed weeks' gestation according to early ultrasonographic estimation or maternal account of last menstrual period.

Exclusion Criteria:

  • Antenatally diagnosed congenital cardio-respiratory anomalies
  • Infants with known chromosomal or genetic abnormalities
  • A prior knowledge of significant fetal distress (diagnosed on the basis of cardiographic monitoring and defined as fetal heart rate <100 beats per minute and/or loss of beat to beat variability, and/or biophysical profile of <4/8)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157989

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Cecile Davey, MD Mount Sinai Hospital, New York
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00157989     History of Changes
Other Study ID Numbers: 04-0164-A
Study First Received: September 8, 2005
Last Updated: September 8, 2006
Health Authority: Canada: Health Canada

Keywords provided by Mount Sinai Hospital, Canada:
Infant, Premature

ClinicalTrials.gov processed this record on July 22, 2014