Ignite Creation Date:
2024-05-06 @ 9:20 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02951130
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2016-10-14
Brief Title:
Milrinone in Congenital Diaphragmatic Hernia
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
Milrinone in Congenital Diaphragmatic Hernia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
Infants with congenital diaphragmatic hernia CDH usually have pulmonary hypoplasia and persistent pulmonary hypertension of the newborn PPHN leading to hypoxemic respiratory failure HRF Pulmonary hypertension associated with CDH is frequently resistant to conventional pulmonary vasodilator therapy including inhaled nitric oxide iNO Increased pulmonary vascular resistance PVR can lead to right ventricular overload and dysfunction In patients with CDH left ventricular dysfunction either caused by right ventricular overload or a relative underdevelopment of the left ventricle is associated with poor prognosis Milrinone is an intravenous inotrope and lusitrope enhances cardiac systolic contraction and diastolic relaxation respectively with pulmonary vasodilator properties and has been shown anecdotally to improve oxygenation in PPHN Milrinone is commonly used during the management of CDH although no randomized trials have been performed to test its efficacy Thirty percent of infants with CDH in the Childrens Hospital Neonatal Database CHND and 22 of late-preterm and term infants with CDH in the Pediatrix database received milrinone In the recently published VICI trial 84 of patients with CDH received a vasoactive medication In the current pilot trial neonates with an antenatal or postnatal diagnosis of CDH will be randomized to receive milrinone or placebo to establish safety of this medication in CDH and test its efficacy in improving oxygenation
Detailed Description:
This is a pilot trial to determine if milrinone infusion in neonates 36 weeks postmenstrual age PMA at birth with CDH would lead to an increase in PaO2 with a corresponding decrease in OI by itself or in conjunction with other pulmonary vasodilators such as iNO at 24 h post-infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| U10HD036790 | NIH | None | httpsreporternihgovquickSearchU10HD036790 |
| UG1HD034216 | NIH | None | None |
| UG1HD027904 | NIH | None | None |
| UG1HD021364 | NIH | None | None |
| UG1HD027853 | NIH | None | None |
| UG1HD040689 | NIH | None | None |
| UG1HD040492 | NIH | None | None |
| UG1HD027851 | NIH | None | None |
| UG1HD087229 | NIH | None | None |
| UG1HD053109 | NIH | None | None |
| UG1HD068278 | NIH | None | None |
| UG1HD068244 | NIH | None | None |
| UG1HD068263 | NIH | None | None |
| UG1HD027880 | NIH | None | None |
| UG1HD053089 | NIH | None | None |
| UG1HD087226 | NIH | None | None |