White Cover & Massage Effects on Bilirubin and Phototherapy in ABO-Incompatible Newborns

NCT06921330 | Completed

• 1 other identifier: E-77192459-050.99-382574
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine the effect of white cover and massage application on bilirubin levels and phototherapy duration in newborns with ABO incompatibility receiving phototherapy.

Conditions

White Cover; Newborn Jaundice; Hyperbilirubinemia, Neonatal; ABO Incompatibility; Newborn Massage; Phototherapy

Keywords

ABO incompatibility; newborn; phototherapy; White cover; massage; Hyperbilirubinemia

Outcome Measures

Primary Outcomes (2)

• Change in bilirubin level

  Capillary bilirubin levels will be measured immediately before the initiation of phototherapy and immediately after the termination of phototherapy. The change in capillary bilirubin levels will be calculated and reported.The unit of measure for bilirubin levels will be milligrams per deciliter (mg/dL).

  From immediately before initiation of phototherapy to immediately after termination of phototherapy

• Duration of phototherapy

  The total duration of phototherapy required until bilirubin levels decreased below the treatment threshold will be recorded.The unit of measure for the duration of phototherapy is hours.

  From initiation to termination of phototherapy

Study Arms (2)

intervention group

EXPERIMENTAL

1. During phototherapy, the phototherapy devices of term newborns with abo incompatibility will be covered with white cover. 2. During phototherapy, infant massage including facial massage, chest massage, arm massage, abdominal massage and leg massage will be applied to term newborns twice a day for 15 minutes each session with an interval of 6 hours.

Other: white cover-newborn massage

control group

NO INTERVENTION

The hospital's clinical routine will be applied to the newborns in the control group.

Interventions

white cover-newborn massage OTHER

A white cover will be covered over the incubator during phototherapy. Baby massage will be applied during phototherapy.

Also known as: white cover and massage

intervention group

Eligibility Criteria

• Age: 12 Hours - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Abo-Incompatibility term babies with a gestational age between 37-42 weeks,
• Does not have a respiratory, cardiovascular, gastrointestinal or neurological disorder or syndrome that would prevent or complicate oral feeding,
• Birth weight of 2500 g and above,
• With phototherapy indication,
• Do not have any health problems other than neonatal jaundice detected in the prenatal period,
• Those with a stable health condition,
• Orally fed,
• No clinical signs of dehydration,
• Do not have any skin problems that would prevent baby massage,
• Newborns with written and verbal informed consent from their families will be included in the study.

You may not qualify if:

• Premature,
• Those with congenital malformations,
• Those with hyperbilirubinemia requiring exchange transfusion,
• Those with Rh hemolytic disease,
• Having a positive culture test (sepsis),
• Those with glucose-6-phosphate dehydrogenase (G6PD) deficiency,
• Birth weight below 2500 grams,
• Those who were referred to another center during the research,
• Discharged early,
• Unexpected complications developed during the research,
• Bronze child syndrome occurs during phototherapy,
• Newborns who develop a pathology that will prevent or complicate oral feeding will not be included in the study.

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Karabük Eğitim Ve Araştırma Hastanesi

Karabük, Karabük Province, 78020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia, Neonatal; Hyperbilirubinemia

Interventions

Massage

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Zeynep ze ÇİFTCİ DEMİRTAŞ, 1

  midwife

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Midwife

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 10, 2025
• Study Start: November 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 4, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)