Comparing intervention levels for the support of blood pressure in extremely premature newborn babies

A pilot randomised trial comparing intervention levels for the support of blood pressure in extremely premature newborn babies

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN83507686

Enrollment

Registered

2012-10-01

Start date

2012-09-01

Completion date

Unknown

Last updated

2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extreme prematurity, neonatal care, circulatory support Pregnancy and Childbirth Preterm spontaneous labour with preterm delivery

Interventions

The study intervention will be allocate babies to a particular blood pressure level at which staff will commence standard treatments for low blood pressure. Patients will be allocated to one of the f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Extremely preterm infants will be eligible to take part in the study if they are: 1. Born at less than or equal to 28 weeks gestation 2. Admitted to our neonatal unit 3. Recruited and randomised in the first 12 hours of life

Exclusion criteria

Exclusion criteria: Known major congenital malformation

Design outcomes

Primary

Measure	Time frame
1. Mean arterial blood pressure during the first week of life (collected hourly for the first 12 hours and 4-hourly thereafter) 2. Use of inotropes and duration of their use	—

Secondary

Measure	Time frame
1. Death or parenchymal brain abnormality on cerebral ultrasound before discharge home 2. Death before discharge home from hospital 3. Periventricular leucomalacia (on cranial ultrasound at or before 36 weeks corrected gestational age) 4. Parenchymal periventricular haemorrhage (on cranial ultrasound on Day 1 and by one week) 5. Other periventricular haemorrhage 6. Acquired gastrointestinal pathology (necrotising enterocolitis, perforation or GI surgery) 7. Treatment for patent ductus arteriosus (drugs or ligation) 8. Maximum serum creatinine in the first 2 weeks of life 9. Maximum serum potassium level 10. Duration of respiratory support 11. Chronic lung disease (defined as oxygen dependency at 36 weeks post-conceptual age) 12. Use of postnatal steroids including hydrocortisone 13. Duration of neonatal care at each British Association of Perinatal Medicine (BAPM) care level (this is the basis for charging for care and a good marker of health service costs) 14. Neurodevelopmental status at routine developmental follow-up	—

Measure

Time frame

1. Death or parenchymal brain abnormality on cerebral ultrasound before discharge home 2. Death before discharge home from hospital 3. Periventricular leucomalacia (on cranial ultrasound at or before 36 weeks corrected gestational age) 4. Parenchymal periventricular haemorrhage (on cranial ultrasound on Day 1 and by one week) 5. Other periventricular haemorrhage 6. Acquired gastrointestinal pathology (necrotising enterocolitis, perforation or GI surgery) 7. Treatment for patent ductus arteriosus (drugs or ligation) 8. Maximum serum creatinine in the first 2 weeks of life 9. Maximum serum potassium level 10. Duration of respiratory support 11. Chronic lung disease (defined as oxygen dependency at 36 weeks post-conceptual age) 12. Use of postnatal steroids including hydrocortisone 13. Duration of neonatal care at each British Association of Perinatal Medicine (BAPM) care level (this is the basis for charging for care and a good marker of health service costs) 14. Neurodevelopmental status at routine developmental follow-up

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026