Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244101
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2005-10-24
Brief Title:
Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome
Sponsor:
Vermont Oxford Network
Organization:
Vermont Oxford Network
Study Overview
Official Title:
Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None