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

NCT ID: NCT06921330

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-03-05

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.

Detailed Description

Hyperbilirubinemia is a common problem seen in the neonatal period characterized by yellow staining of the skin and sclera, causing an increase in total serum bilirubin >5 mg/dl. Neonatal jaundice is observed in 60% of term newborns and 80% of preterm newborns. Hyperbilirubinemia is usually physiologic and disappears within a few days. If jaundice becomes severe and pathologic hyperbilirubinemia occurs, it can lead to kernicterus (bilirubin accumulation in parts of the brain) or death.Therefore, any infant with hyperbilirubinemia with elevated serum bilirubin levels requires serious attention and treatment.

ABO incompatibility is a cause of indirect hyperbilirubinemia leading to pathologic jaundice. Newborns with ABO incompatibility tend to have higher bilirubin levels due to impaired bilirubin excretion during the neonatal period. ABO incompatibility is observed in approximately 25% of mother-infant pairs. ABO incompatibility may develop when the mother's blood type is O and the baby's blood type is A or B. In ABO incompatibility, maternal anti-A or anti-B antibodies cross the placenta and bind to A/B antigens on the surface of fetal erythrocytes. Antibody-coated erythrocytes are destroyed in the reticuloendothelial system. Bilirubin increases as a result of heme catabolism that is released with the destruction of erythrocytes, and this is reflected in the clinic as neonatal jaundice. In the presence of ABO incompatibility, early screening and close follow-up of newborns in terms of development of hyperbilirubinemia is very important. Traditional treatment modalities for jaundice due to ABO incompatibility are phototherapy and exchange transfusion.

The primary treatment of neonatal jaundice is phototherapy. The efficacy of phototherapy depends on the phototherapy light source, light intensity, the distance between the phototherapy light and the newborn, and the body surface area exposed to light. Phototherapy has potential side effects such as hyperthermia, dehydration, diarrhea, bronze baby syndrome and skin burns in newborns. Therefore, the use of phototherapy should be minimized and solutions should be found to shorten the duration of phototherapy. To increase the effectiveness of phototherapy treatment, a reflective material can be added to the phototherapy. White fabric that can be used as a reflector can reflect the scattered phototherapy light. When fabrics made of reflective materials are hung on the phototherapy device, they can capture light that may be scattered from the baby to the environment and reflect the light back to the baby. The white fabric can increase the irradiance and thus increase bilirubin conversion. Bilirubin is excreted from the body through feces. Removal of bilirubin from the body reduces jaundice. Massage decreases bilirubin levels by increasing the frequency of bowel movements in newborn babies.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

intervention group

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.

Group Type: EXPERIMENTAL

white cover-newborn massage

Intervention Type: OTHER

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

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

white cover-newborn massage

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

Intervention Type: OTHER

Other Intervention Names

white cover and massage

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 12 Hours
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karabuk University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep ÇİFTCİ DEMİRTAŞ

Midwife

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeynep ze ÇİFTCİ DEMİRTAŞ, 1

Role: PRINCIPAL_INVESTIGATOR

midwife

Locations

Karabük Eğitim Ve Araştırma Hastanesi

Karabük, Karabük Province, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Zeynep ÇİFTCİ DEMİRTAŞ, midwife

Role: CONTACT

zeynepciftcidemirtas@gmail.com

+905076339774 ext. +905076339774

Other Identifiers

E-77192459-050.99-382574

Identifier Type: -

Identifier Source: org_study_id