Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233324
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2005-10-03
Brief Title:
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
Surfactant Positive Airway Pressure and Pulse Oximetry Trial SUPPORT in Extremely Low Birth Weight Infants
Status:
COMPLETED
Status Verified Date:
2019-04
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:
SUPPORT
Brief Summary:
This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation In addition these infants within 2 hours of birth had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges 85-89 or 91-95 This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants
Detailed Description:
Study subjects were infants of 24 07ths to 27 67th weeks at birth for which a decision has been made to provide full resuscitation as required Infants 27 weeks or less gestation completed weeks by best obstetric estimate were enrolled because more than 80 of such infants in the Network are intubated usually early in their neonatal course The feasibility trial demonstrated that the five NICHD centers involved could reduce intubation in the delivery room to less than 50 of such infants if they are not intubated for surfactant We excluded infants of 23 weeks or less in view of their extremely high mortality and morbidity and their almost universal need for delivery room intubation for resuscitation Secondary studies included neuroimagingMRI growth and breathing outcomes
Strata There were two randomization strata infants of 24 07ths to 25 67ths weeks and infants of 26 07ths-27 67ths weeks by best obstetrical estimate
Randomization
Randomization was stratified by gestational age group occurred prior to delivery for consented deliveries and was performed by utilizing specially prepared double-sealed envelopes Deliveries were randomized as a unit thus multiples twins triplets etc were randomized to the same arm of the trial
Informed Consent
Parents were approached prior to delivery for informed consent and their infants enrolled at delivery
Study Intervention Mode of Ventilatory Support The intervention began after birth when the infant was given to the resuscitation team The conduct of the resuscitation followed usual guidelines and once stabilized all Control infants in both strata received prophylacticearly surfactant within one hour of age whereas all Treatment infants were placed on CPAPPEEP following stabilization and were intubated only for resuscitation indications
Pulse Oximeter Allocation
Infants were randomized to receive either a high- or low-saturation of peripheral oxygen SpO2 as monitored by a study oximeter immediately following NICU admission with a maximum allowable delay of two hours following admission
The SUPPORT Trial recruitment was temporarily paused on November 23 2005 based on concern regarding pulse oximeter readings 95 and due to concern regarding separation of the two arms of the oximetry portion of the study Further analyses were performed which showed that infants on room air accounted for a significant portion of pulse oximetry saturations above 95 Separation of the two groups was reanalyzed based on time spent in room air and the duration of time spent at individual SpO2 values which both showed group differences The trial was restarted on February 6 2006
Follow-up Subjects will be seen for a follow-up visit at 18-22 months corrected age to look at neurodevelopment
Extended follow-up Subjects enrolled in the NeuroimagingMRI secondary study will also be seen for a follow-up visit at 6-7 years to look at later school-age development Subjects attending the 6-7 year follow-up visit will be invited to participate in this secondary study which will analyze the relationship of salivary cortisol and dehydroepiandrosterone DHEA to a blood pressure and adiposity b prenatal and postnatal growth and c DNA methylation patterns
Strata There were two randomization strata infants of 24 07ths to 25 67ths weeks and infants of 26 07ths-27 67ths weeks by best obstetrical estimate
Randomization
Randomization was stratified by gestational age group occurred prior to delivery for consented deliveries and was performed by utilizing specially prepared double-sealed envelopes Deliveries were randomized as a unit thus multiples twins triplets etc were randomized to the same arm of the trial
Informed Consent
Parents were approached prior to delivery for informed consent and their infants enrolled at delivery
Study Intervention Mode of Ventilatory Support The intervention began after birth when the infant was given to the resuscitation team The conduct of the resuscitation followed usual guidelines and once stabilized all Control infants in both strata received prophylacticearly surfactant within one hour of age whereas all Treatment infants were placed on CPAPPEEP following stabilization and were intubated only for resuscitation indications
Pulse Oximeter Allocation
Infants were randomized to receive either a high- or low-saturation of peripheral oxygen SpO2 as monitored by a study oximeter immediately following NICU admission with a maximum allowable delay of two hours following admission
The SUPPORT Trial recruitment was temporarily paused on November 23 2005 based on concern regarding pulse oximeter readings 95 and due to concern regarding separation of the two arms of the oximetry portion of the study Further analyses were performed which showed that infants on room air accounted for a significant portion of pulse oximetry saturations above 95 Separation of the two groups was reanalyzed based on time spent in room air and the duration of time spent at individual SpO2 values which both showed group differences The trial was restarted on February 6 2006
Follow-up Subjects will be seen for a follow-up visit at 18-22 months corrected age to look at neurodevelopment
Extended follow-up Subjects enrolled in the NeuroimagingMRI secondary study will also be seen for a follow-up visit at 6-7 years to look at later school-age development Subjects attending the 6-7 year follow-up visit will be invited to participate in this secondary study which will analyze the relationship of salivary cortisol and dehydroepiandrosterone DHEA to a blood pressure and adiposity b prenatal and postnatal growth and c DNA methylation patterns
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10HD040498 | NIH | None | httpsreporternihgovquickSearchU10HD040498 |
| U10HD021364 | NIH | None | None |
| U10HD021373 | NIH | None | None |
| U10HD021385 | NIH | None | None |
| U10HD027851 | NIH | None | None |
| U10HD027853 | NIH | None | None |
| U10HD027856 | NIH | None | None |
| U10HD027871 | NIH | None | None |
| U10HD027880 | NIH | None | None |
| U10HD027904 | NIH | None | None |
| U10HD034216 | NIH | None | None |
| U10HD036790 | NIH | None | None |
| U10HD040461 | NIH | None | None |
| U10HD040492 | NIH | None | None |
| U10HD040689 | NIH | None | None |
| U10HD053089 | NIH | None | None |
| U10HD053109 | NIH | None | None |
| U10HD053119 | NIH | None | None |
| U10HD053124 | NIH | None | None |
| UL1RR024128 | NIH | None | None |
| UL1RR024139 | NIH | None | None |
| UL1RR024979 | NIH | None | None |
| UL1RR024982 | NIH | None | None |
| UL1RR024989 | NIH | None | None |
| UL1RR025008 | NIH | None | None |
| M01RR000633 | NIH | None | None |
| M01RR000750 | NIH | None | None |
| M01RR008084 | NIH | None | None |
| U10HD021397 | NIH | None | None |
| U10HD040521 | NIH | None | None |