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 woman's bedside. If the cord is clamped within 20 seconds, the neonatal team will choose whether care for the baby is provided at the woman's 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 the researchers 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 are 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 is provided at the bedside. If the cord is clamped within 20 seconds, the neonatal team choose whether care for the baby is provided at the woman's bedside or at the side of the room. Women who take part in the study are asked to complete a short postal questionnaire six weeks after the birth, and another one year after the birth. Around the child's second birthday the parents are 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 (UK)
When is the study starting and how long is it expected to run for?
March 2013 to September 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Lindsay Armstrong-Buisseret
Lindsay.Armstrong-Buisseret@nottingham.ac.uk
Trial website
http://www.nottingham.ac.uk/nctu/trials/pregnancy-and-childbirth.aspx
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
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 884 4938
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
The 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.
Ethics approval
NRES Committee East Midlands - Nottingham 2, 23/07/2012, ref: 12/EM/0283
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 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
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Feasibility outcomes for the original pilot trial:
1. Number of women recruited in each hospital
2. Proportion of potentially eligible women recruited
3. Reasons for non-recruitment (medical, parental, logistic, other)
4. Spectrum of gestational age and neonatal outcome among recruits
5. Compliance with the trial interventions, and reasons for non-compliance
6. Completeness of data collection for main outcomes
7. Views of women and their partners on recruitment, randomisation and the interventions
8. Proportion lost to follow up after discharge from hospital, and reasons for loss to follow up
Added 01/07/2016:
As the primary outcomes planned for the main Cord Trial were death and intraventricular haemorrhage, these were the pre-specified main outcomes for the analysis by allocated group for the Cord Pilot Trial.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/03/2013
Overall trial end date
01/09/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women likely to have a live birth 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: 261
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
01/02/2015
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 details
c/o Dr Maria Koufali
Research & Innovation
Nottingham Integrated Clinical Research Centre
C Floor
South Block
Queen's Medical Centre Campus
Nottingham
NG7 2UH
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (UK) - Programme Grants for Applied Research; Grant Codes: RP-PG-0609-10107
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Outcome data at discharge from hospital to be published in 2016. Follow-up of women at 1 year is expected to be published in 2017 and assessment of the children at 2 years of age (corrected for gestation at birth) in 2018.
Intention to publish date
01/01/2017
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24981366
2015 protocol update in: http://www.ncbi.nlm.nih.gov/pubmed/26370414
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28446203
2017 women's views and experiences of two alternative consent pathways: http://www.ncbi.nlm.nih.gov/pubmed/28886747
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28923985
Publication citations
-
Protocol
Pushpa-Rajah A, Bradshaw L, Dorling J, Gyte G, Mitchell EJ, Thornton J, Duley L, , Cord pilot trial - immediate versus deferred cord clamping for very preterm birth (before 32 weeks gestation): study protocol for a randomized controlled trial., Trials, 2014, 15, 258, doi: 10.1186/1745-6215-15-258.
-
Protocol
Bradshaw LE, Pushpa-Rajah A, Dorling J, Mitchell EJ, Duley L; Cord Pilot Trial Collaborative Group, Cord pilot trial: update to randomised trial protocol., Trials, 2015, 16, 1, 407, doi: 10.1186/s13063-015-0936-2.
Additional files
- ISRCTN21456601_PROTOCOL_v6.2_08Sep16.pdf Uploaded 10/11/2016