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Amphia Premature Infant Pain Study

NCT01276366 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-01-17

No results posted yet for this study

Summary

Last thirty years, many research was performed concerning pain in the newborn. These investigations showed us the negative effects of pain in the neonatal period. Our research concerns the choice of analgesics for the premature newborn during a heel lance. Newborns with a gestational age of 32-37 weeks are randomly assigned over three groups. They can receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or sucrose.

The primary objective of the Amphia Premature Infant Pain study, is to investigate whether there is a difference in PIPP-scores in premature newborns who undergo a heel lance, receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in newborns receiving breast milk compared to sucrose. And the investigators presume that breast feeding has the same analgesic effect as giving supplemental breast milk.

Conditions

  • Premature Infant
  • Breast Feeding, Exclusive
  • Puncture Skin

Interventions

OTHER

breast feeding

Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child.

OTHER

supplemental breast milk

In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.

OTHER

sucrose

In the third group, newborns receive sucrose 1ml 24% two minutes before procedure, followed by non-nutritive sucking. During the procedure the newborn lies in his cot.

Sponsors & Collaborators

  • Amphia Hospital

    lead OTHER

Principal Investigators

  • RHT v Beek, phd · Amphia Hospital Breda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-01
Primary Completion
2011-08-01
Completion
2012-04-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01276366 on ClinicalTrials.gov