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Newborn Cortical Response to Pain and Non Pharmacological Analgesia

NCT03389789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-10-03

No results posted yet for this study

Summary

Minor painful procedures are frequently performed on newborn infants and non-pharmacological analgesia is commonly used. As more than one analgesic method may be applied simultaneously in clinical practice, the relative contribution and efficacy of analgesic components still needs to be further elucidated. In the present study neonatal cortical brain response during four types of non-pharmacological analgesia (oral glucose, expressed breastmilk, maternal holding plus oral glucose, maternal holding plus breastfeeding) will be studied. The aim is to assess the differential effect of oral solutions (glucose, breastmilk), when given alone or in combination with maternal relationship (holding, breastfeeding). The study will test the hypothesis that the mother-infant relationship would improve the analgesic effect of oral solutions.

Conditions

  • Analgesia

Interventions

OTHER

Oral glucose solution + maternal holding

Infant will receive both the oral glucose solution and the contact with the mother

OTHER

Breastfeeding

Infants will be breastfed

OTHER

Oral glucose solution

Infant will receive only oral glucose solution without contact with the mother

OTHER

Oral expressed breastmilk

Infant will receive only oral expressed breast milk without contact with the mother

Sponsors & Collaborators

  • IRCCS Burlo Garofolo

    lead OTHER

Principal Investigators

  • Fabio Barbone, Prof · Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy

  • Stefano Bembich, MSC · Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-02
Primary Completion
2017-05-31
Completion
2017-05-31

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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 NCT03389789 on ClinicalTrials.gov