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

ISRCTN	ISRCTN83507686
DOI	https://doi.org/10.1186/ISRCTN83507686
Secondary identifying numbers	2012-v4

Submission date: 13/07/2012
Registration date: 01/10/2012
Last edited: 26/04/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Although many of the problems of extremely preterm babies may be related to disturbances of the circulatory system (body system that controls blood flow), there is a lack of agreement regarding interventions (treatment) for low blood pressure in these babies. The lower limit of blood pressure requiring support in premature babies is still uncertain.

Who can participate?
This study will recruit newborn babies of 23-28 weeks gestation admitted to a single neonatal unit.

What does the study involve?
A total of 60 extremely preterm babies, will be randomised to one of three different blood pressure intervention levels at which standard treatments for low blood pressure will be started:
1. Active: Support blood pressure if it falls below 30mmHg
2. Moderate: Support blood pressure if it falls below the babys gestation in mmHg
3. Permissive: Do not intervene unless low blood pressure is accompanied by evidence of impaired blood flow
This is a initial study to determine whether different intervention levels achieve different blood pressures and rates of drug treatment. It will also compare short and long term complications as well as organ blood flow between the groups.

What are the possible benefits and risks of participating?
There will no immediate benefit to those taking part, but information from this study may help other premature babies and may be used to plan larger studies looking at clinical outcomes. These intervention levels are all in use in various different neonatal units. The study will not carry appreciable benefits or risks for participants, beyond those associated with extreme prematurity itself.

Where is the study run from?
This is a single centre study to be conducted in Barts Health NHS Trust.

When is study starting and how long is it expected to run for?
The study will commence in autumn 2012 and is expected to run for 2 years.

Who is funding the study?
The study will commence as an internally funded study by Centre for Paediatrics, Blizard Institute, Barts and the London School of Medicine and Dentistry, but external funding has been applied for.

Who is the main contact?
Dr Steve Kempley
s.t.kempley@qmul.ac.uk

Contact information

Dr Stephen Kempley
Scientific

Centre for Paediatrics
Blizard Institute
4, Newark Street
London
E1 2AT
United Kingdom

Phone	+44 (0)20 7882 2615
Email	s.t.kempley@qmul.ac.uk

Study information

Study design	Randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A pilot randomised trial comparing intervention levels for the support of blood pressure in extremely premature newborn babies
Study objectives	Different approaches to blood pressure intervention will result in different usage rates of inotropic agents and levels of achieved blood pressure, in extremely premature newborn infants (less than or equal to 28 weeks gestation). These findings, together with the rates of complications found in the whole study, will be used to design a larger multicentre study.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Extreme prematurity, neonatal care, circulatory support
Intervention	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 following three intervention levels: 1. Active: Support blood pressure if it falls below 30mmHg 2. Moderate: Support blood pressure if it falls below the babys gestation in mmHg 3. Permissive: Do not intervene unless low blood pressure is accompanied by evidence of impaired blood flow In each arm of the trial, patients will receive the same treatments for low blood pressure, once they reach the intervention level.
Intervention type	Other
Primary outcome measure	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 outcome measures	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
Overall study start date	01/09/2012
Completion date	31/08/2014

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	60
Total final enrolment	60
Key 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
Key exclusion criteria	Known major congenital malformation
Date of first enrolment	01/09/2012
Date of final enrolment	31/08/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Centre for Paediatrics

London
E1 2AT
United Kingdom

Sponsor information

Barts Health NHS Trust (UK)
Hospital/treatment centre

c/o Mr Gerry Leonard
Queen Mary Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2EF
England
United Kingdom

Website	http://www.bartsandthelondon.nhs.uk/our-services/research-and-development/
"ROR"	https://ror.org/00b31g692

Funders

Funder type

Hospital/treatment centre

Centre for Paediatrics, Blizard Institute, Barts and the London School of Medicine and Dentistry (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to a lack of approval from the research ethics committee to do so.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/11/2018	26/11/2019	Yes	No
Results article	results	01/11/2018	26/11/2019	Yes	No
Results article		01/05/2019	19/04/2021	Yes	No

Editorial Notes

26/04/2021: IPD sharing statement.
19/04/2021: Publication reference added.
26/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
07/12/2016: No publications found in PubMed, verifying study status with principal investigator.