Cord Pilot Trial
| ISRCTN | ISRCTN21456601 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21456601 |
| Secondary identifying numbers | 13070; 108150; 12OB006 |
- Submission date
- 28/02/2013
- Registration date
- 28/02/2013
- Last edited
- 25/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Scientific
Nottingham Clinical Trials Unit
Nottingham Health Science Partners
Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 884 4938 |
|---|---|
| cord@nottingham.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 to request a patient information sheet |
| Scientific title | Immediate cord clamping versus deferred cord clamping for preterm birth before 32 weeks gestation: a pilot randomised trial |
| Study acronym | CORD |
| Study objectives | 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(s) | NRES Committee East Midlands - Nottingham 2, 23/07/2012, ref: 12/EM/0283 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2013 |
| Completion date | 01/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | UK Sample Size: 261 |
| Key inclusion criteria | Women likely to have a live birth before 32 weeks gestation, regardless of mode of birth or whether cephalic or breech presentation |
| Key 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 |
| Date of first enrolment | 01/03/2013 |
| Date of final enrolment | 01/02/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NG7 2UH
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Dr Maria Koufali
Research & Innovation
Nottingham Integrated Clinical Research Centre
C Floor, South Block
Queen's Medical Centre Campus
Nottingham
NG7 2UH
England
United Kingdom
| Website | https://www.nuh.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/05y3qh794 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 30/06/2014 | Yes | No | |
| Protocol article | protocol update | 14/09/2015 | Yes | No | |
| Protocol file | version v6.2 | 08/09/2016 | 10/11/2016 | No | No |
| Results article | results | 26/04/2017 | Yes | No | |
| Other publications | women's views and experiences of two alternative consent pathways | 09/09/2017 | Yes | No | |
| Results article | results | 01/01/2018 | Yes | No | |
| Results article | 1-year follow-up results | 21/02/2019 | 25/02/2019 | Yes | No |
Additional files
- ISRCTN21456601_PROTOCOL_v6.2_08Sep16.pdf
- Uploaded 10/11/2016
Editorial Notes
25/02/2019: Publication reference added.
20/09/2017: Publication reference added.
12/09/2017: Publication reference added.
28/04/2017: Publication reference added.
10/11/2016: Uploaded protocol (not peer reviewed).
13/06/2016: The target number of participants was changed from 110 to 261.
21/04/2015: The overall trial end date was changed from 28/02/2014 to 01/09/2017.
