sing milrinone in babies with high blood pressure in the lungs soon after birth

Phase 3

• Conditions: Persistent pulmonary hypertension of the newborn (PPHN); Circulatory System; Pulmonary hypertension of newborn (persistent)

• Registration Number: ISRCTN12949496
• Lead Sponsor: The Royal College of Surgeons in Ireland

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30524749 protocol 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36385642/ (added 18/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-07
• Study Completion: 2020-02-01
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

All infants with a gestation = 34 weeks and a birth weight = 2000 grams admitted to the neonatal intensive care unit with a clinical diagnosis of PPHN, and commenced on iNO will be deemed potentially eligible for this study. The process of iNO initiation in PPHN on clinical grounds is standardised in the NICUs. In addition, the infants must satisfy the following criteria:
1. = 10 postnatal days of life and within 24 hrs of admission
2. Echocardiography diagnosis of PPHN (see below)
3. Absence of significant congenital heart defect excluding a small atrial septal defect or ventricular septal defect (measuring less than 3mm)
4. Indwelling arterial line; oxygenation index =25 on at least two consecutive arterial blood gas samples at least 20 minutes apart

Exclusion Criteria

1. Lethal congenital anomalies or obvious syndrome
2. Bleeding diathesis (abnormal coagulation screen/platelet <100,000/ mm3)
3. The presence of Intraventricular haemorrhage
4. Diastolic Hypotension (defined as a diastolic blood pressure less than the 3rd centile for any given gestation) unresponsive to medical treatment (=30 mL/kg fluid bolus and = 2 inotropes of at least 10 µg/ kg/min)
5. Hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia
6. Evidence of renal impairment (Creatinine > 100micromol/l)
7. Severe Hypovolaemia: Heart rate > 180, capillary refill > 5 seconds, urine output < 0.5ml/kg/hour, in addition to diastolic hypotension mentioned above

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time on iNO therapy and the time spent on invasive ventilation

Secondary Outcome Measures

Name	Time	Method
The incidence of the use of other inotropes; critically low LV and RV function and output measured by echocardiography and a non-invasive cardiac output monitor (NICOM); the rate of adverse effects associated with milrinone including the incidence of hypotension; and the pre-discharge outcomes in the two groups.