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Clinical Trials/ISRCTN78390996
ISRCTN78390996CompletedNot 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 enrollmentStarted: July 30, 2009Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

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:
  • •9. Infants at high risk for necrotising enterocolitis
  • •10. Asphyxiated infants
  • •11. Infants with feeding intolerance
  • •12. Infants without bowel sounds
  • •13. Infants with oesophageal atresia or tracheal oesophageal fistula
  • •14. Infants with active phase persistent pulmonary hypertension of the newborn

Investigators

Sponsor
niversity College London Hospitals NHS Foundation Trust (UK)

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