Journal article
The use of milrinone in neonates with persistent pulmonary hypertension of the newborn - a randomised controlled trial pilot study (MINT 1)
Journal of perinatology, Vol.43(2), pp.168-173
02/2023
DOI: 10.1038/s41372-022-01562-8
PMCID: PMC9666925
PMID: 36385642
Abstract
OBJECTIVE: To assess the impact of milrinone administration on time spent on nitric oxide (iNO) in infants with acute pulmonary hypertension (aPH). We hypothesized that intravenous milrinone used in conjunction with iNO would reduce the time on iNO therapy and the time spent on invasive ventilation in infants >= 34 weeks gestation with a diagnosis of aPH. We aimed to assess the practicality of instituting the protocol and contributing to a sample size calculation for a definitive multicentre study.
STUDY DESIGN: This was a multicentre, randomized, double-blind, two arm pilot study, with a balanced (1:1) allocation. Infants with a gestation >= 34 weeks and a birth weight >= 2000 grams aPH, an oxygenation index of >= 10, and commenced on iNO were eligible. Participants on iNO were assigned to either a milrinone infusion (intervention) or a normal saline infusion (placebo) for up to 35 h. The primary outcome was time on iNO and feasibility of conducting the protocol.
RESULTS: The trial was terminated early after 4 years of enrollment due to poor recruitment. Four infants were allocated to the intervention arm and 5 to the placebo arm. The groups were well matched for baseline variables. No differences were seen in any of the primary or secondary outcomes.
CONCLUSION: Conducting an interventional trial in the setting of acute pulmonary hypertension in infants is not feasible using our current approach. Future studies in this area require alternative trial design to improve recruitment as this topic remains understudied in the neonatal field.
Details
- Title: Subtitle
- The use of milrinone in neonates with persistent pulmonary hypertension of the newborn - a randomised controlled trial pilot study (MINT 1)
- Creators
- Afif El-Khuffash - Rotunda HospitalPatrick J. McNamara - Stead Family Dept Pediat, Div Neonatol, Iowa City, IA USAColm Breatnach - Rotunda Hosp, Dept Neonatol, Dublin, IrelandNeidin Bussmann - Rotunda Hosp, Dept Neonatol, Dublin, IrelandAisling Smith - Rotunda Hosp, Dept Neonatol, Dublin, IrelandOliver Feeney - Rotunda Hosp, Dept Clin Res, Dublin, IrelandElizabeth Tully - Rotunda Hosp, Dept Clin Res, Dublin, IrelandJoanna Griffin - Rotunda Hosp, Dept Clin Res, Dublin, IrelandWillem P. de Boode - Radboud University NijmegenBrian Cleary - Rotunda Hosp, Dept Pharm, Dublin, IrelandOrla Franklin - Our Ladys Childrens Hosp Crumlin, Dept Paediat Cardiol, Dublin, IrelandEugene Dempsey - Infant
- Resource Type
- Journal article
- Publication Details
- Journal of perinatology, Vol.43(2), pp.168-173
- Publisher
- Springer Nature
- DOI
- 10.1038/s41372-022-01562-8
- PMID
- 36385642
- PMCID
- PMC9666925
- ISSN
- 0743-8346
- eISSN
- 1476-5543
- Number of pages
- 6
- Grant note
- CTN-PP-2014-872 / Irish Health Research Board
- Language
- English
- Electronic publication date
- 11/16/2022
- Date published
- 02/2023
- Academic Unit
- Stead Family Department of Pediatrics; Neonatology; Internal Medicine
- Record Identifier
- 9984353842402771
Metrics
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