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

NCT ID: NCT00244101

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 648 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2011-06-30

Brief Summary

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.

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.

Conditions

Respiratory Distress Syndrome, Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PS Group

Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.

Group Type: ACTIVE_COMPARATOR

PS Group

Intervention Type: DRUG

Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.

NCPAP Group

Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.

Group Type: EXPERIMENTAL

NCPAP Group

Intervention Type: DEVICE

Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.

ISX Group

Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.

Group Type: EXPERIMENTAL

ISX Group

Intervention Type: DRUG

Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.

Interventions

PS Group

Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.

Intervention Type: DRUG

NCPAP Group

Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.

Intervention Type: DEVICE

ISX Group

Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.

Intervention Type: DRUG

Other Intervention Names

Prophylactic Surfactant Group; Nasal CPAP group; Intubation, Surfactant Administration, Extubation to Nasal CPAP. ENSURE.

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 26 Weeks
• Maximum Eligible Age: 29 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vermont Oxford Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger F Soll, MD

Role: PRINCIPAL_INVESTIGATOR

Vermont Oxford Network

Michael Dunn, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook and Women's Hospital, Toronto, Ontario, Canada

Locations

Vermont Oxford Network

Burlington, Vermont, United States

Countries

United States

References

Dunn MS, Kaempf J, de Klerk A, de Klerk R, Reilly M, Howard D, Ferrelli K, O'Conor J, Soll RF; Vermont Oxford Network DRM Study Group. Randomized trial comparing 3 approaches to the initial respiratory management of preterm neonates. Pediatrics. 2011 Nov;128(5):e1069-76. doi: 10.1542/peds.2010-3848. Epub 2011 Oct 24.

Reference Type: RESULT

PMID: 22025591 (View on PubMed)

Other Identifiers

CHRMS 03-233

Identifier Type: -

Identifier Source: org_study_id