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IRCT20261001071249N1 IRCT 2026-10-14 University of Baghdad Comparing White Reflective Covers and Massage Alongside Phototherapy to Reduce Jaundice in Full-Term Newborn 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) 2027-01-01 anticipated 150 Pending https://irct.ir/trial/94026 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Other design features: This study will employ a four-arm, 2 × 2 factorial randomized controlled trial design to evaluate the independent and combined effects of a white reflective cover and infant massage as adjuncts to standard phototherapy in term neonates with hyperbilirubinemia. Participants will be allocated to one of four groups: standard phototherapy alone, phototherapy with a white reflective cover, phototherapy with infant massage, or phototherapy with both interventions. The study will assess bilirubin clearance rate, phototherapy duration, and length of hospital stay. The factorial design will allow evaluation of the main effects of each intervention and their interaction effect, Randomization description: **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. N/A Neonatal hyperbilirubinemia. Intervention 1: Intervention group 1: Standard phototherapy with a white reflective cover as an adjunct intervention for term neonates with hyperbilirubinemia. Intervention 2: Intervention group 2: Standard phototherapy with infant massage as an adjunct intervention for term neonates with hyperbilirubinemia. Intervention 3: Intervention group 3: Standard phototherapy with both a white reflective cover and infant massage as adjunct interventions for term neonates with hyperbilirubinemia. Intervention 4: Control group: Standard phototherapy alone for term neonates with hyperbilirubinemia, according to the hospital's routine clinical protocol. Yes - There is a plan to make this available What will be shared: 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. When: 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. To whom: The data and documents may be made available to qualified researchers for scientifically valid research purposes, subject to applicable ethical and institutional requirements. Conditions: 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. Where to obtain: Requests may be submitted to the principal investigator or the corresponding institutional research contact. How to obtain: 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. Comments: No directly identifying participant information will be shared. Data sharing will be subject to participant confidentiality, ethical approval, and institutional policies.
public Hadeer Abdulameer Shalaan Farhan
Al-Qadisiyah
Al-Diwaniyah Center Iraq 58001 +964 782 207 7655 hadeer.abd2504m@conursing.uobaghdad.edu.iq University of Baghdad scientific Dr. Zaid Waheed Ajil
Baghdad Center
Baghdad Center Iraq 10001 +964 781 438 1748 zaid_ahjil@conursing.uobaghdad.edu.iq College of Nursing, University of Baghdad Iraq 1. Term neonates with a gestational age of 37 to 41 completed weeks.2. Neonates diagnosed with hyperbilirubinemia and requiring standard phototherapy according to the treating physician's assessment and applicable clinical guidelines.3. Neonates admitted to the selected study setting during the recruitment period.4. Written informed consent obtained from the parent or legal guardian before enrollment.5. Neonates who meet all study eligibility criteria and can receive the assigned intervention according to the study protocol. no limit 40 days Both 1. Neonates with major congenital anomalies or serious clinical conditions that may interfere with the study interventions or outcome assessment.2. Neonates requiring urgent treatment or additional therapeutic interventions that would prevent adherence to the study protocol.3. Neonates with contraindications to infant massage or to the use of the white reflective cover, as determined by the approved protocol and clinical assessment.4. Neonates whose clinical circumstances prevent reliable measurement of the study outcomes. Neonatal j Neonatal jaundice due to excessive hemolysis, unspecified Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group 1: Standard phototherapy with a white reflective cover as an adjunct intervention for term neonates with hyperbilirubinemia. Intervention group 2: Standard phototherapy with infant massage as an adjunct intervention for term neonates with hyperbilirubinemia. Intervention group 3: Standard phototherapy with both a white reflective cover and infant massage as adjunct interventions for term neonates with hyperbilirubinemia. Control group: Standard phototherapy alone for term neonates with hyperbilirubinemia, according to the hospital's routine clinical protocol. Bilirubin clearance rate in term neonates with hyperbilirubinemia receiving phototherapy. Timepoint: At baseline before the study interventions, and every 12 hours during phototherapy until phototherapy is discontinued, according to the study protocol. Method of measurement: Bilirubin clearance rate will be calculated from serial total serum bilirubin (TSB) measurements obtained using the hospital laboratory's validated method. The rate will be calculated as the change in TSB concentration divided by the elapsed time between measurements and expressed in mg/dL per hour. Measurements will be performed using consistent procedures across all four study groups. Duration of phototherapy in hours. Timepoint: From initiation of phototherapy until phototherapy is discontinued according to the treating physician's clinical assessment and applicable guidelines. Method of measurement: Phototherapy duration will be calculated in hours from the recorded start time to the recorded discontinuation time, using the participant's clinical records. University of Baghdad Approved 2026-09-13 Ethics Committee of Al-Qadisiyah Health Directorate, Research and Development Training Center Al-Qadisiyah Health Directorate, Research and Development Training Center, Al-Diwaniyah, Al-Qadisiyah, Iraq Al-Diwaniyah Center Al-Qadisiyah Iraq