Impact of Breast Milk on Cortical Pain Response in Newborns

NCT05961904 | Completed

• 1 other identifier: Ozgul2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Analgesia; breastmilk; cortical pain response; heal prick procedure; Near-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• The rScO2 measure was the primary outcome.

  A near-infrared spectroscopy device was used to monitor regional cerebral oxygen saturation (rScO2). Pain increases oxygen consumption with changes occurring in the rScO2 measure.

  2 months

Secondary Outcomes (1)

• The Neonatal Pain, Agitation, and Sedation scale

  2 months

Study Arms (2)

Study group

EXPERIMENTAL

Study group with receive orally breast milk

Other: Breastmilk

Control group

NO INTERVENTION

no intervention

Interventions

Breastmilk OTHER

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

Also known as: Human milk

Study group

Eligibility Criteria

• Age: 2 Days - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Neonates born before 37 weeks of gestation

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcın City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Bulut O, Topaloglu SC, Bulut N, Hocaoglu M, Arslanoglu S. Impact of breast milk on cortical pain response in newborns during the heel prick procedure: a randomized controlled trial. J Perinatol. 2024 Nov;44(11):1675-1681. doi: 10.1038/s41372-024-02081-4. Epub 2024 Aug 12.

  PMID: 39134667 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Milk, Human

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Ozgul Bulut

  Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcın City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 27, 2023
• Study Start: June 1, 2021
• Primary Completion: August 30, 2021
• Study Completion: September 15, 2021
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)