Efficacy of a White Reflective Cover and Massage as Adjuncts to Standard Phototherapy on Bilirubin Clearance Rate, Phototherapy Duration, and Length of Hospital Stay in Term Neonates with Hyperbilirubinemia: A Randomized Controlled Trial (RCT)

To evaluate the effects of a white reflective cover and infant massage, separately and in combination, as adjuncts to standard phototherapy on bilirubin clearance rate in term neonates with hyperbilirubinemia.

A single-center, four-group, 2 × 2 factorial randomized controlled trial involving 150 term neonates is planned. Participants will be randomly allocated to the four study groups. The study will evaluate the independent effects of each intervention and their interaction.

The study will be conducted in the Neonatal Intensive Care Unit of the Maternal and Child Teaching Hospital in Al-Diwaniyah, Al-Qadisiyah Governorate, Iraq. After eligibility screening and written informed consent, participants will be randomized to one of the four groups. Clinical data and serial total serum bilirubin measurements will be collected using a standardized protocol.

Participants will be term neonates born at 37 to 41 completed weeks of gestation with hyperbilirubinemia requiring phototherapy. Written informed consent will be obtained from parents or legal guardians. Neonates with major congenital anomalies, serious clinical conditions interfering with the interventions or outcome assessment, or contraindications to the interventions will be excluded.

Participants will receive one of four interventions: standard phototherapy alone; standard phototherapy with a white reflective cover; standard phototherapy with infant massage; or standard phototherapy with both a white reflective cover and infant massage.

The primary outcome is bilirubin clearance rate, assessed using serial total serum bilirubin measurements. Secondary outcomes are phototherapy duration and length of hospital stay. Outcomes will be compared across the four study groups.

**Randomization Description** Eligible term neonates with hyperbilirubinemia will be individually randomized into one of four study groups using a computer-generated random allocation sequence. A block randomization method will be used to help maintain a balanced number of participants across the four groups throughout the recruitment period. The random sequence will be generated using appropriate statistical software before participant enrollment. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes prepared according to the randomization sequence by an individual who is not involved in participant recruitment or outcome assessment. After eligibility confirmation and obtaining written informed consent, the next envelope in sequence will be opened to determine the participant's group assignment. The four groups will receive: (1) standard phototherapy alone; (2) standard phototherapy with a white reflective cover; (3) standard phototherapy with infant massage; or (4) standard phototherapy with both a white reflective cover and infant massage. No stratification will be used unless specified in the approved study protocol.

De-identified individual participant data, the study protocol, statistical analysis plan, informed consent form, clinical study report, and data dictionary related to the randomized controlled trial evaluating a white reflective cover and infant massage as adjuncts to standard phototherapy in term neonates with hyperbilirubinemia.

The data and documents planned for sharing will become available after completion of the study and publication of the main results, subject to ethical approval and institutional requirements. They will remain available for a period determined by the responsible institution and applicable regulations.

The data and documents may be made available to qualified researchers for scientifically valid research purposes, subject to applicable ethical and institutional requirements.

Access will be considered for research proposals with a clear scientific purpose. Data will be shared only in de-identified form, subject to confidentiality safeguards, applicable ethical approvals, and any required data-use agreement.

Requests may be submitted to the principal investigator or the corresponding institutional research contact.

Researchers should submit a written request describing the research question, proposed analyses, and intended use of the data. Requests will be reviewed by the responsible investigator and, where required, the relevant institutional or ethics committee. Access will be provided only after approval and completion of any required agreements.

No directly identifying participant information will be shared. Data sharing will be subject to participant confidentiality, ethical approval, and institutional policies.