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

Phase 1

• Conditions: Persistent Pulmonary Hypertension of the Newborn; MedDRA version: 19.1Level: LLTClassification code 10053592Term: Newborn persistent pulmonary hypertensionSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2014-002988-16-IE
• Lead Sponsor: Royal College of Surgeons in Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-09
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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 and is standardised in the NICUs and is detailed in Appendix 2. The decision is made by the attending physician In addition; the infants must satisfy the following criteria:

1) = 10 postnatal days of life and within 4 days 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) Oxygenation index of = 10 measured obtained from an arterial blood sample and calculated using the following formula:
OI = (Mean airway pressure × FiO2 × 100) ÷ (paO2 in kilopascals)

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified