Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005774
Status:
TERMINATED
Last Update Posted:
2015-06-08
First Post:
2000-06-01
Brief Title:
Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
Early Surfactant Followed by Nasal CPAP to Reduce the Use of Mechanical Ventilation Without Additional Morbidity in Infants 1250- 2000 Grams With RDS
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial was stopped after 7 months for lack of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Surfactant 2
Brief Summary:
Mechanical ventilation MV of preterm infants with respiratory distress syndrome RDS is associated with lung injury and nosocomial infection Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment This multi-center randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure CPAP in infants 1250-2000g with RDS reduced mechanical ventilation usage without added complications Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP or standard practice surfactant according to current center practice only after initiation of mechanical ventilation to see whether the experimental method would reduce the need for subsequent mechanical ventilation
Detailed Description:
Mechanical ventilation MV of preterm infants with respiratory distress syndrome RDS is associated with lung injury and nosocomial infection Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment The role of surfactant therapy in the management of larger infants with respiratory distress syndrome RDS was unclear In many neonatal intensive care units these infants were routinely managed with continuous positive airway pressure CPAP alone
This trial tested whether early use of surfactant combined with CPAP would ameliorate the course of RDS without an increased risk of death Primary study outcomes were measures of use of mechanical ventilation and thereby likely reduction in risk of ventilator-associated morbidity
Eligible infants were randomized before the infant is 12 hours of age to receive either early surfactant followed by extubation within 30 minutes and application of CPAP intervention group or surfactant according to current center practice only after initiation of mechanical ventilation control group
The trial was stopped after 7 months for lack of recruitment
This trial tested whether early use of surfactant combined with CPAP would ameliorate the course of RDS without an increased risk of death Primary study outcomes were measures of use of mechanical ventilation and thereby likely reduction in risk of ventilator-associated morbidity
Eligible infants were randomized before the infant is 12 hours of age to receive either early surfactant followed by extubation within 30 minutes and application of CPAP intervention group or surfactant according to current center practice only after initiation of mechanical ventilation control group
The trial was stopped after 7 months for lack of recruitment
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 |
|---|---|---|---|
| U10HD027856 | NIH | None | None |
| U10HD021364 | NIH | None | None |
| U10HD034216 | NIH | None | None |
| U10HD034167 | NIH | None | None |
| U10HD021397 | NIH | None | None |
| U10HD027853 | NIH | None | None |
| U10HD027871 | NIH | None | None |
| U10HD021415 | NIH | None | None |
| U10HD027904 | NIH | None | None |
| U10HD027881 | NIH | None | None |
| U10HD021385 | NIH | None | None |
| U10HD027851 | NIH | None | None |
| U10HD027880 | NIH | None | None |
| M01RR000070 | NIH | None | None |
| U01HD036790 | NIH | None | None |
| M01RR008084 | NIH | None | None |
| M01RR006022 | NIH | None | None |
| M01RR000750 | NIH | None | None |
| M01RR000997 | NIH | None | None |
| M01RR001032 | NIH | None | httpsreporternihgovquickSearchM01RR001032 |