MedTrace Logo

Impact of Breast Milk on Cortical Pain Response in Newborns

NCT05961904 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-07-27

No results posted yet for this study

Summary

Background:Newborns are exposed to painful procedures for many different reasons in the first days of their life. If pain is not relieved effectively in these newborns, neurodevelopmental and behavioral problems may occur in the short- and long-term.

Objective:This study is aimed to investigate the effects of breast milk on cortical pain response and behavioral response in newborns during heel-prick procedure.

Design: A prospective, randomized controlled trial was conducted on newborns born in a university hospital. Healthy-term newborns, undergoing heel blood sampling for newborn screening, were enrolled in the study. Infants were randomly assigned to study group with receive orally 2 ml breast milk (n=45) or a control group with no intervention (n=45) before the heel prick. A near-infrared spectroscopy device was used to monitor regional cerebral oxygen saturation (rScO2), while neonatal pain expression was assessed by Neonatal Pain, Agitation, and Sedation Scale (N-PASS). The rScO2 measure was the primary outcome, while the N-PASS score, heart rate, SaO2, and crying time were the secondary outcomes.

Conditions

  • Pain Management

Interventions

OTHER

Breastmilk

Study group with receive orally 2 ml breast milk before the heel prick.

Sponsors & Collaborators

  • Istanbul Medeniyet University

    lead OTHER

Principal Investigators

  • Ozgul Bulut · Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcın City Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-08-30
Completion
2021-09-15

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

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 NCT05961904 on ClinicalTrials.gov