White Cover and Massage Impact on Bilirubin Levels and Phototherapy Duration in Newborns

Not Applicable

Completed

• Conditions: Newborn Jaundice; Hyperbilirubinemia, Neonatal; Newborn Massage; Phototerapy; White Cover
• Interventions: Other: White cover

• Registration Number: NCT06209489
• Lead Sponsor: Karabuk University

Brief Summary

This study aimed to examine the effect of white cover and massage application on newborns' bilirubin level and duration of phototherapy in newborns 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 seen in 60% of term newborns and 80% of preterm newborns. Hyperbilirubinemia is usually physiological and disappears within a few days. Jaundice may worsen and lead to kernicterus (accumulation of bilirubin in some parts of the brain) or death if pathological hyperbilirubinemia occurs. Therefore, every baby with hyperbilirubinemia and high serum bilirubin levels requires serious attention and treatment. The primary treatment for neonatal jaundice is phototherapy. The effectiveness of phototherapy depends on the phototherapy light source, light intensity, distance between the phototherapy light and the newborn, and the body surface area exposed to the light. Phototherapy has potential side effects in newborns such as hyperthermia, dehydration, diarrhea, bronze baby syndrome, and skin burns. For this reason, 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 reflector material can be added to the phototherapy. White fabric, which can be used as a reflector, can reflect scattered phototherapy light. When fabrics made of reflective materials are hung over the phototherapy device, they can capture the light that may scatter from the baby to the environment and reflect the light back to the baby. White fabric may increase irradiance and therefore lead to increased bilirubin conversion.Studies have reported that massage applied before phototherapy is effective in reducing the bilirubin level in babies with hyperbilirubinemia. Bilirubin is eliminated from the body through defecation. Removing bilirubin from the body reduces jaundice. Massage reduces bilirubin levels by increasing the frequency of bowel movements in newborn babies.

Study Timeline

• Study First Submitted: 2023-12-30
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-17
• Study Start: 2024-03-01
• Primary Completion: 2024-06-29
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Term babies with 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
İntervention group	White cover	1. White fabric will be covered over the incubator for term newborns during phototherapy. 2. During phototherapy, term newborns will receive a baby massage, including facial massage, chest massage, arm massage, abdominal massage and leg massage, twice a day for 15 minutes.

Primary Outcome Measures

Name	Time	Method
Newborn massage	2 times 15 minutes at 12 hour intervals	Baby massage will be applied during phototherapy.
White cover	24 hours	A white cover will be covered over the incubator during phototherapy.

Trial Locations

Locations (1)

Karabuk University; 🇹🇷 Karabük, Turkey