Status:
COMPLETED
Parental Touch Trial (Petal)
Lead Sponsor:
Paediatric Neuroimaging Research Group
Collaborating Sponsors:
Wellcome Trust
University of Oxford
Conditions:
Infant Development
Pain, Procedural
Eligibility:
All Genders
Up to 7 years
Phase:
NA
Brief Summary
This is a two centre two-arm randomised controlled interventional trial. We aim to determine whether parental touch prior to a painful clinical procedure provides effective analgesia in neonates.
Detailed Description
This is a multicentre randomised-controlled interventional trial, with two research sites (John Radcliffe Hospital, Oxford, and Royal Devon and Royal Devon and Exeter Hospital, Devon). In this study w...
Eligibility Criteria
Inclusion
- Participants born at the John Radcliffe Hospital, Oxford or the Royal Devon and Exeter Hospital, Devon
- Neonates born at or after 35+0 weeks gestation
- Neonates with a postnatal age of 7 days or less
- Neonates who clinically require a heel lance
- Neonates for whom parents/guardians have given written informed consent for inclusion in the trial
Exclusion
- Intraventricular haemorrhage (IVH) \> grade II
- Received any analgesics or sedatives in the last 24 hours
- Congenital malformation or genetic condition known to affect neurological development
- Born to mothers who have a history of substance abuse.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2023
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04901611
Start Date
September 1 2021
End Date
February 7 2023
Last Update
February 28 2023
Active Locations (1)
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1
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 9DU