Management of Hypotension In the Preterm Infant

• Status: Terminated
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The HIP trial is a large pragmatic, multinational, randomised trial of two different strategies for the management of hypotension in extremely low gestational age newborns (Standard with dopamine versus a restricted with placebo approach).

HYPOTHESIS: A restricted approach to the management of hypotension in extremely low gestational age newborns will result in improved neonatal and long-term developmental outcomes.

PRIMARY OBJECTIVE: To determine whether a restricted approach to the management of hypotension compared to using dopamine as first line pressor agent in infants born less than 28 weeks of gestation within the first 72 hrs after birth (transitional period), improves survival without significant brain injury at 36 weeks postmenstrual age (PMA) and improves survival without moderate or severe neurodevelopmental disability at 2 years corrected age.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College Cork
• Collaborators: BrePco Biopharma Limited; Clininfo S.A.; Coombe Women and Infants University Hospital; Cork University Hospital; GABO:mi; Institut National de la Santé Et de la Recherche Médicale, France; Institute for the Care of Mother and Child, Prague, Czech Republic; Katholieke Universiteit Leuven; KU Leuven; National Maternity Hospital, Ireland; Royal College of Surgeons, Ireland; Royal Jubilee Maternity Service, Belfast; St. Justine's Hospital; University College, London; University Hospital, Antwerp; University of Alberta
• Treatments: Dopamine; Dopamine Agents

Criteria

Inclusion Criteria:

1. Gestational age at birth less than 28 completed weeks, i.e. up to and including 27 weeks and 6 days.

2. Within 72 hours of birth

3. An indwelling arterial line, either umbilical or peripheral (e.g. radial, posterior tibial), suitably calibrated and zeroed, to monitor BP with the measuring dome at the level of the infant's mid-axillary line when supine

4. A pre-trial cerebral ultrasound scan demonstrating no evidence of grade 3 or 4 haemorrhage intraventricular haemorrhage (IVH)(i.e. intraparenchymal echodensity or echolucency, with or without acquired cerebral ventriculomegaly)

5. A mean blood pressure 1 mmHg or more below a mean BP value equivalent to the gestational age in completed weeks, which persists over a 15 minute period (mean BP < gestational age)

Exclusion Criteria:

1. Considered non-viable by attending clinicians.

2. Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosus, small atrial and/or ventricular septal defect). Infants known to require surgical treatment e.g. congenital diaphragmatic hernia, trache-oesophageal fistula, omphalocele, gastroschisis. Neuromuscular disorders. Frank hypovolaemia. Hydrops Fetalis.

3. Cranial ultrasound abnormality grade 3 IVH or more prior to enrolment