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IRCT20250704066372N1 IRCT 2025-07-26 Kashan University of Medical Sciences White Plastic Covering and Its Effect on Newborns' Jaundice Investigating the effect of white plastic covering around the phototherapy unit on hyperbilirubinemia in neonates 2025-07-24 anticipated 140 Complete https://irct.ir/trial/85048 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This will be an open-label trial due to the visible nature of the intervention (presence or absence of white plastic cover around the phototherapy unit). Neither caregivers nor investigators will be blinded to the group allocation. However, the data analyst will be blinded to the group assignments to reduce detection bias, Randomization description: In this study, block randomization will be used to ensure balanced sample sizes between the two groups. The unit of randomization will be the individual neonate, and no stratification will be applied. The allocation list will be generated using computer-based random number generation with a block size of four, ensuring a 1:1 assignment ratio between the intervention and control groups. The randomization sequence will be prepared by an independent person who will not be involved in patient recruitment. To ensure allocation concealment, sealed, opaque, and sequentially numbered envelopes will be used. Each envelope will contain the assigned group and will only be opened after confirming eligibility and obtaining informed consent from the parents. N/A Neonatal Hyperbilirubinemia. Intervention 1: Intervention group: Preterm neonates will receive standard phototherapy with a white plastic cover placed around the phototherapy unit. The cover is made of glossy white plastic, 2 mm thick, covering three sides of the unit. One side remains open for care and observation. Intervention 2: Control group: Preterm neonates will receive standard phototherapy without any plastic cover around the unit. All other care and monitoring will be identical to the intervention group. Yes - There is a plan to make this available What will be shared: Deidentified Participant Dataset – Phototherapy Trial in Preterm Neonates Includes anonymized individual-level data related to primary and secondary outcomes such as serum bilirubin levels, duration of phototherapy, and incidence of side effects. No personal identifiers are included. When: The data files will be available starting 6 months after publication of the study results and will remain accessible for a period of 3 years. To whom: Deidentified IPD and supporting documents will be shared upon reasonable request with researchers affiliated with academic or healthcare institutions. Access for individuals from non-academic or commercial entities will be considered on a case-by-case basis and subject to ethical approval. Conditions: Access to deidentified IPD and supporting documents will be granted for secondary analyses that are methodologically sound and ethically approved, such as meta-analyses or validation studies. Requests must be submitted in writing along with a brief study protocol. All requests will be reviewed by the principal investigator and the institutional ethics committee. Decisions will be based on scientific merit, ethical considerations, and alignment with the original consent provided by participants. Data will be shared through secure data transfer platforms. Where to obtain: Applicants who wish to access the deidentified IPD or supporting documents should contact the Principal Investigator via email. The preferred method of communication is email. Requests can be sent to: Seyed Amirabbas Sharif amirsharif.md@gmail.com 00989133198472 How to obtain: Applicants must submit a written request via email along with a brief description of the intended analysis and a summary protocol. The request will be reviewed by the principal investigator and then forwarded to the institutional ethics committee for approval, if applicable. The entire process, including ethical review and data preparation, may take approximately 4 to 8 weeks. If approved, data will be shared through a secure transfer method, and the applicant must agree to terms of use and confidentiality. Comments:
public Seyed Amirabbas Sharif
Kashan University of Medical Sciences, Shahid Beheshti Hospital, Qotb-e Ravandi Boulevard, Amir Kabir District, Kashan, Isfahan Province, Iran
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5558 9444 amirsharif.md@gmail.com Kashan University of Medical Sciences scientific Seyed Amirabbas Sharif
Kashan University of Medical Sciences, Shahid Beheshti Hospital, Qotb-e Ravandi Boulevard, Amir Kabir District, Kashan, Isfahan Province, Iran
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5558 9444 amirsharif.md@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Neonates with a gestational age ≥ 35 weeks Indication for phototherapy according to the Bhutani nomogram Diagnosis of non-hemolytic neonatal hyperbilirubinemia Parental consent for participation in the study no limit no limit Both Neonates with major congenital anomalies Presence of hemolytic disease (e.g., ABO or Rh incompatibility) Use of drugs affecting bilirubin metabolism, such as phenobarbital Use of herbal remedies (e.g., jujube, shir-khesht, or similar traditional agents) Neonates suspected of having an infection P59 Neonatal jaundice from other and unspecified causes Treatment - Devices Other Intervention group: Preterm neonates will receive standard phototherapy with a white plastic cover placed around the phototherapy unit. The cover is made of glossy white plastic, 2 mm thick, covering three sides of the unit. One side remains open for care and observation. Control group: Preterm neonates will receive standard phototherapy without any plastic cover around the unit. All other care and monitoring will be identical to the intervention group. Change in total serum bilirubin level before and after phototherapy. Timepoint: Before intervention (at admission), and at 12 hours, 24 hours, and at discharge after the start of phototherapy. Method of measurement: Total serum bilirubin will be measured using standard laboratory blood tests with a validated automated biochemical analyzer. Blood samples will be collected through venipuncture at specified time points. Duration of phototherapy (in hours). Timepoint: From the start of phototherapy to its discontinuation (measured in hours). Method of measurement: Duration of phototherapy will be measured by recording the start and end time of phototherapy in each patient’s medical chart. The total duration will be calculated in hours. Rate of bilirubin reduction per hour. Timepoint: Calculated between each bilirubin measurement timepoint (e.g., 0–12h, 12–24h). Method of measurement: The rate of bilirubin reduction will be calculated by subtracting the initial serum bilirubin level from the level measured at subsequent time points, divided by the number of hours between measurements. Side effects (hyperthermia, rash, dehydration). Timepoint: Every 6 hours during phototherapy. Method of measurement: Side effects will be monitored and recorded every 6 hours during phototherapy by trained nurses. Hyperthermia will be defined as axillary temperature > 37.5°C. Skin rash and signs of dehydration will be clinically assessed and documented. Kashan University of Medical Sciences Approved 2025-03-02 Research Ethics Committee of the Faculty of Medicine and Dentistry - Kashan University of Medical Sc Shahid Beheshti Hospital, Qotb-e Ravandi Boulevard, Kashan, Isfahan Province, Iran Kashan Isfehan Iran (Islamic Republic of)