The Use of Milrinone in Neonates with Persistent Pulmonary Hypertension of the Newborn: A Randomised Controlled Trial Pilot Study

Withdrawn

• Conditions: Persisterende pulmonale hypertensie van de pasgeborene; Persistent pulmonary hypertension of the neonate; 10019280; 10028971

• Registration Number: NL-OMON48755
• Lead Sponsor: RCSI Clinical Research Centre, Royal College of Surgeons in Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1) Gestational age *34 weeks and birth weight *2000 grams
2) * 10 postnatal days of life and within 4 days of admission
3) Echocardiographic diagnosis of PPHN
4) Absence of significant congenital heart defect excluding a small atrial
septal defect or ventricular septal defect (measuring< 3mm)
5) Oxygenation index of * 10

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 *g/ 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
<p>The primary outcome of this study is the time on iNO in hours and the time on<br /><br>invasive ventilation.</p><br>