Condition category
Pregnancy and Childbirth
Date applied
13/07/2012
Date assigned
01/10/2012
Last edited
01/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 baby’s 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Kempley

ORCID ID

Contact details

Centre for Paediatrics
Blizard Institute
4
Newark Street
London
E1 2AT
United Kingdom
+44 (0)20 7882 2615
s.t.kempley@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2012-v4

Study information

Scientific title

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

Acronym

Study hypothesis

The main hypothesis is that 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

Not provided at time of registration

Study design

Randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 baby’s 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/09/2012

Overall trial end date

31/08/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

60

Participant exclusion criteria

Known major congenital malformation

Recruitment start date

01/09/2012

Recruitment end date

31/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Paediatrics
London
E1 2AT
United Kingdom

Sponsor information

Organisation

Barts Health NHS Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.bartsandthelondon.nhs.uk/our-services/research-and-development/

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes