ISRCTN - ISRCTN21456601: Cord Pilot Trial

Plain English Summary

Background and study aims
In the UK one in every 70 babies is born more than eight weeks before their due date (very preterm). These very premature babies have immature lungs, and often need help with breathing, feeding and keeping warm. Usually at the birth of a premature baby, the umbilical cord is clamped and cut straight away, the baby is placed in a plastic wrap to retain heat, and then cared for by the neonatologist (a doctor or nurse who is a specialist in the care of newborn babies) on a special table at the side of the room.
Clamping the cord stops blood flow between the placenta (organ that connects the developing foetus to the uterine wall to allow nutrient uptake, waste elimination, and gas exchange via the mother's blood supply) and the baby. If the cord is not clamped straight away, this blood flow may continue for several minutes, potentially transferring blood from the placenta to the baby.
Waiting a few minutes before clamping the cord may help the baby to adjust to life outside the womb. As it is not known when the best time to clamp the cord for very preterm births is, this study is being done. The study is comparing clamping the cord after at least two minutes (deferred cord clamping) with clamping the cord within 20 seconds.
For deferred cord clamping, care for the baby will be provided at the womans bedside. If the cord is clamped within 20 seconds, the neonatal team will choose whether care for the baby is provided at the womans bedside or at the side of the room. In both cases the baby will receive the same care at birth, just in different places.
This is an initial small study, to help decide whether it would be possible to do a much larger trial. Finding out which of the two approaches to care is better for babies and their mothers will need the large study. Information from this study will help us to conduct the large study well.

Who can participate?
Women who are expected to give birth more than eight weeks before their due date.

What does the study involve?
Women who take part in the study will be randomly allocated to one of the two groups (1) cord clamping after at least two minutes, or (2) cord clamping within 20 seconds. If the cord is clamped after at least two minutes, care for the baby will be provided at the bedside. If the cord is clamped within 20 seconds, the neonatal team will choose whether care for the baby is provided at the womans bedside or at the side of the room.
Women who take part in the trial will be asked to complete a short postal questionnaire six weeks after the birth, and another one year after the birth. Around the childs second birthday the parents will be contacted to complete another questionnaire and to arrange a visit to find out how their child is doing.

Where is the study run from?
Nottingham Clinical Trials Unit, Nottingham Health Science Partners, Queen's Medical Centre, Derby Road
Nottingham, NG7 2UH

When is the study starting and how long is it expected to run for?
The study started in April 2013 and will continue to recruit women until March 2014.

Who is funding the study?
National Institute for Health Research, UK

Who is the main contact?
Angela Pushpa-Rajah, Trial Manager
Angela.pushpa-rajah@nottingham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lelia Duley

ORCID ID

Contact details

Nottingham Clinical Trials Unit
Nottingham Health Science Partners
Queen's Medical Centre
Derby Road
Notts
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 8844936
cord@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13070; 108150; 12OB006

Study information

Scientific title

Immediate cord clamping versus deferred cord clamping for preterm birth before 32 weeks gestation: a pilot randomised trial

Acronym

CORD

Study hypothesis

Our primary hypothesis is that for children born before 32 weeks gestation immediate cord clamping is associated with higher death or neurosensory disability at two years of age (corrected for gestation at birth) than deferred cord clamping. A trial to test this hypothesis would need to be large and multicentre. This protocol is for a pilot trial to assess the feasibility such a study.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13070

Ethics approval

NRES Committee East Midlands Nottingham 2, 23/07/2012, REC reference: 12/EM/0283

Study design

Randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Topic: Reproductive Health and Childb, Generic Health Relevance and Cross Cutting Themes; Subtopic: Reproductive Health and Childb (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Reproductive Health & Childbirth, Paediatrics

Intervention

1. Deferred cord clamping: clamping the cord after at least two minutes.
2. Immediate cord clamping: clamping the cord within 20 seconds.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

For this pilot trial to assess feasibility of the main trial, outcomes will be:
1. Number of women recruited in each hospital
2. Proportion of potentially eligible women recruited
3. Reasons women are not recruited
4. Range of gestational age and outcome for the baby amongst women recruited
5. Compliance with the trial interventions (timing of cord clamping), and reasons for non-compliance
6. Completeness of data collection for main trial outcomes (see above)
7. Views of women and their partners on recruitment, randomisation and the trial interventions
8. Proportion lost to follow up after discharge from hospital, and reasons for loss to follow up

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/03/2013

Overall trial end date

28/02/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Women will be eligible for the study if they are likely to have a livebirth before 32 weeks gestation, regardless of mode of birth or whether cephalic or breech presentation.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

UK Sample Size: 110

Participant exclusion criteria

1. Monochorionic twins (from an ultrasound scan) or clinical evidence of twin-twin transfusion syndrome
2. Triplets or higher order multiple pregnancy
3. Known congenital malformation

Recruitment start date

01/03/2013

Recruitment end date

28/02/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham Clinical Trials Unit
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust (UK)

Sponsor type

Hospital/treatment centre

Website

https://www.nuh.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR (UK) - Programme Grants for Applied Research; Grant Codes: RP-PG-0609-10107

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