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ISRCTN
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ISRCTN21456601
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DOI
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10.1186/ISRCTN21456601
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Pre-term Cord Clamping Trial
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Scientific title
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Immediate cord clamping with neonatal care at the roomside, versus deferred cord clamping with neonatal care at the bedside for preterm birth before 32 weeks gestation: a pilot randomised trial
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Acronym
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N/A
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Serial number at source
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13070
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Study hypothesis
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In the UK 1 in every 100 babies is born before 32 weeks gestation (very preterm). These babies have immature lungs and kidneys, and often need help with breathing, feeding and other life support. Usually at the birth of a preterm baby, the umbilical cord is clamped and cut straight away, and the baby is taken to a special table at the side of the room to be cared for by the neonatologist. Clamping the cord stops blood flow between the placenta and the baby. Waiting a few minutes before clamping the cord may help the baby to adjust to life outside the womb.
It is not known when it is the best time to clamp the cord for very preterm births. This trial wants to look at waiting for at least two minutes before cord clamping (deferred cord clamping) and providing neonatal care for the baby at the bedside and compare this with the clamping the cord before 20 seconds and providing care for the baby to the roomside for neonatal care (as in current practice). In both cases, the baby will receive the same care at birth but just in different places. So, if the cord has not been clamped and cut immediately then care will be given at the mother’s bedside. If the cord is clamped and cut immediately, then care will be given at the roomside.
This is a pilot study, to assess whether it would be possible to do a much larger trial, to find out what are the best ways of recruiting women into the trial and collecting the study information. This pilot study will provide us with initial information about the benefits and possible problems for babies, but a larger study will then be needed to assess this properly.
More detail can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13070
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Lay summary
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Not provided at time of registration
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Ethics approval
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12/EM/0283
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Study design
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Pilot randomised trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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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
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/03/2013
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Anticipated end date
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28/02/2014
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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UK Sample Size: 110
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Interventions
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1. Deferred cord clamping, Deferred cord clamping after at least 2 minutes, with neonatal care at bedside
2. Clamping the cord before 20 seconds and providing care for the baby to the roomside for neonatal care (as in current practice)
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Primary outcome measure(s)
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Number of women recruited in each hospital; Timepoint(s): 12 Months
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Secondary outcome measure(s)
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1. Completeness of data collection for main trial outcomes; Timepoint(s): 24 months
2. Compliance with the trial interventions & reasons for non-compliance; Timepoint(s): 12 months
3. Proportion lost to follow up after discharge from hospital, and reasons for loss to follow up; Timepoint(s): 24 months
4. Proportion of potentially eligible women recruited; Timepoint(s): 12 months
5. Reasons for non-recruitment (medical, parental,logistic, other); Timepoint(s): 12 months
6. Sprectrum of gestational age and neonatal outcome among recruits; Timepoint(s): 12 months
7. Views of women & their partners on recruitment, randomisation & the interventions; Timepoint(s): 12 months
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Sources of funding
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NIHR (UK) - Programme Grants for Applied Research; Grant Codes: RP-PG-0609-10107
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Trial website
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Publications
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Contact name
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Prof
Leila
Duley
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Address
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Clinical Trials Unit B39
School of Community Health Sciences
Queens Medical Centre
Derby Road
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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Country
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United Kingdom
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Email
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lelia.duley@nottingham.ac.uk
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Sponsor
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Nottingham University Hospitals NHS Trust (UK)
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Address
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Queens Medical Centre
Derby Road
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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Country
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United Kingdom
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Sponsor website:
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https://www.nuh.nhs.uk/
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Date applied
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28/02/2013
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Last edited
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28/02/2013
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Date ISRCTN assigned
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28/02/2013
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