Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome

January 4, 2023 updated by: Vermont Oxford Network

Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome

The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The "Delivery room management of premature infants at high risk of respiratory distress syndrome" protocol compares three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk of respiratory distress syndrome. The three approaches to post-delivery care include:

  1. Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
  2. Early stabilization on nasal continuous positive airway pressure (NCPAP) with selective intubation and surfactant administration for clinical indications.
  3. Intubation, prophylactic surfactant administration shortly after delivery and rapid extubation to nasal CPAP.

The primary null hypothesis for this study is that no difference will be found in chronic lung disease and/or mortality at 36 weeks adjusted age in premature infants at high risk of RDS, depending on the method of post-delivery stabilization.

The study is a randomized, multicenter trial conducted at participating Vermont Oxford Network Centers. Participating centers will demonstrate competency in the use of nasal CPAP by successfully completing a web-based, educational program and utilizing nasal CPAP in a minimum of 20 infants in their NICU.

Infants likely to be delivered to women presenting to a participating Vermont Oxford Network Center at high risk of premature delivery at gestational age 26 + 0 to 29 + 6 weeks will be eligible for inclusion. Specific inclusion criteria that must be met prior to randomization include:

  1. imminent delivery
  2. no potentially life-threatening congenital anomaly or genetic syndrome
  3. no known lung maturity
  4. antenatal steroid status known
  5. written and informed consent obtained prior to delivery.

Exclusion criteria will include:

  1. stillborn infants (Apgar score of 0 at one minute of age) or
  2. infants noted to have a potentially life-threatening congenital anomaly or genetic syndrome noted immediately after delivery.

Eligible infants will have consent obtained prior to delivery. They will be stratified into two groups: 26 + 0 to 27 + 6 weeks gestation and 28 + 0 to 29 + 6 weeks gestation. Shortly before delivery, infants will be randomized to one of the three stabilization strategies detailed below:

  1. Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support (PS group).
  2. Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications (NCPAP group).
  3. Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP (ISX group).

Infants requiring intubation for respiratory failure during this study (in any of the three groups) may be stabilized on either conventional or high-frequency ventilation. Specific criteria regarding target ranges for blood gases and indications for extubation, subsequent surfactant dosing, management of extubation, and criteria for reintubation, are all detailed in the protocol.

The primary outcome measure is chronic lung disease (defined as documented requirement for supplemental oxygen or respiratory support) or mortality at 36 weeks adjusted age. Secondary outcome measures include a variety of clinical outcomes, as well as issues regarding duration of hospital stay and other resource utilization. Long-term outcomes will be measured by a health care questionnaire at two years of age. A sample size of over 895 infants will be required to demonstrate a 25% reduction in the risk of chronic lung disease at 36 weeks adjusted age.

Study Type

Interventional

Enrollment (Actual)

648

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Vermont Oxford Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Infants likely to be delivered to women presenting to a participating Vermont Oxford Network Center at high risk of premature delivery at gestational age 26 + 0 to 29 + 6 weeks will be eligible for inclusion. Specific inclusion criteria that must be met prior to randomization include:

  1. Imminent delivery
  2. No potentially life-threatening congenital anomaly or genetic syndrome
  3. No known lung maturity
  4. Antenatal steroid status known
  5. Written, informed consent obtained (on admission or prior to delivery).

Exclusion Criteria:

  1. Stillborn (Apgar score of 0 at one minute of age)
  2. Noted to have a potentially life-threatening congenital anomaly or genetic syndrome noted immediately after delivery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PS Group
Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
Drug: PS Group
Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
Other Names:
  • Prophylactic Surfactant Group
Experimental: NCPAP Group
Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
Device: NCPAP Group
Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
Other Names:
  • Nasal CPAP group
Experimental: ISX Group
Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
Drug: ISX Group
Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
Other Names:
  • Intubation, Surfactant Administration, Extubation to Nasal CPAP. ENSURE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death or Chronic Lung Disease
Time Frame: at 36 weeks postmenstrual age
at 36 weeks postmenstrual age
Death
Time Frame: 36 weeks adjusted age
36 weeks adjusted age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vermont Oxford Network

Investigators

  • Principal Investigator: Roger F Soll, MD, Vermont Oxford Network
  • Principal Investigator: Michael Dunn, MD, Sunnybrook and Women's Hospital, Toronto, Ontario, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 24, 2005

First Submitted That Met QC Criteria

October 24, 2005

First Posted (Estimate)

October 25, 2005

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRMS 03-233

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Distress Syndrome, Newborn

Clinical Trials on PS Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe