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Clinical Trials/ISRCTN78390996
ISRCTN78390996
Completed
Not Applicable

A double-blinded randomised controlled study to assess the effect of sucrose versus sterile water on cortical responses to painful events in newborn infants

niversity College London Hospitals NHS Foundation Trust (UK)0 sites60 target enrollmentJuly 30, 2009
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity College London Hospitals NHS Foundation Trust (UK)
Enrollment
60
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 30, 2009
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity College London Hospitals NHS Foundation Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. In\-patients on the labour ward, post\-natal ward, transitional care unit (TCU) and special care baby unit (SCBU) at the Elizabeth Garrett Anderson \& Obstetrics Hospital, University College London Hospital (UCLH), UK
  • •2\. Both males and females, aged between 37 and 45 weeks post\-menstrual age (PMA)
  • •Babies will only be studied when a blood test is needed for clinical purposes.

Exclusion Criteria

  • •Prior to each study the infant's well\-being and their suitability to be studied will be assessed by the clinicians in the research group; studies will be postponed or cancelled if the infant is considered to be unfit to take part.
  • •1\. Infants who are asleep
  • •2\. Infants who are fed 30 minutes or less before the heel lance
  • •3\. Signs of tissue damage on the lower limbs
  • •4\. Intraventricular haemorrhage or periventricular leukomalacia
  • •5\. Infants who have had previous surgery
  • •6\. Infants who are receiving analgesics or sedatives
  • •7\. Infants who are born to mothers who are diabetic or opioid users
  • •8\. Infants born with congenital malformations or genetic conditions
  • •In addition, infants that fall into the following criteria will be excluded from the study as use of 24% sucrose water is contraindicated:

Outcomes

Primary Outcomes

Not specified

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