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IRCT20251121068065N10 IRCT 2026-06-30 Shahre-kord University of Medical Sciences Comparison of the effect of immediate and routine kangaroo mother care on the outcomes and physiological indicators of premature babies hospitalized in the neonatal intensive care unit Comparison of the effect of immediate and routine kangaroo mother care on the outcomes and physiological indicators of premature babies hospitalized in the neonatal intensive care unit 2026-07-01 anticipated 52 Complete https://irct.ir/trial/90942 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Stratified block randomization will be performed according to gestational age, with participants stratified into two categories (≤32 weeks and 33–37 weeks of gestation). Within each stratum, participants will be randomly allocated to the intervention or control group using permuted blocks of sizes 4 and 6 with a 1:1 allocation ratio. Allocation concealment will be ensured through sequentially numbered, sealed, opaque envelopes that are opened only after participant enrollment. Blocks will be filled progressively within each stratum until the required sample size of 52 participants is achieved, ensuring balanced allocation between study groups. N/A The effect of kangaroo care on adverse outcomes and physiological indicators of premature infants. Intervention 1: Control group (Routine Kangaroo Care): Preterm infants will receive skin-to-skin care after stabilization of physiological status, typically initiated approximately 3 days after birth, according to routine clinical practice. In this method, the mother is positioned in a semi-upright sitting posture on a kangaroo mother care (KMC) chair. The infant, wearing only a diaper and a cap, is placed in an upright position—commonly referred to as the “frog position”—on the mother’s chest between the breasts to ensure direct skin-to-skin contact. Intervention 2: Intervention group (Immediate Kangaroo Care): Preterm infants will receive early skin-to-skin contact with their mothers within 10 minutes to 24 hours after birth. The infant will be placed directly on the mother’s chest to establish continuous skin-to-skin contact. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Dr. Roya Choupani
Faculty of Medicine, Rahmatieh Educational Complex, Shahrekord, Iran.
Shahrekord Iran (Islamic Republic of) ۸۸۱۵۷۱۳۴۷۱ +98 913 721 5546 royachoopani51@gmail.com Shahre-kord University of Medical Sciences scientific Dr. Jafar Moghaddasi
Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences, Rahmatieh, Shahrekord, Chaharmahal and Bakhtiari Province, Iran
Shahrekord Iran (Islamic Republic of) ۸۸۱۵۷۱۳۴۷۱ +98 913 181 1328 moghaddasi@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Gestational age minimum 26 weeks and maximum 37 weeks. Absence of major congenital anomalies (e.g., diaphragmatic hernia, gastroschisis, omphalocele, or meningomyelocele). Initiation of the intervention within the first 24 hours after birth. Stable respiratory status with no increase in ventilator settings during the 6 hours preceding the intervention. Written informed consent obtained from parents or legal guardians. No active bleeding. Absence of a central venous catheter, peripherally inserted central catheter (PICC), chest tube, or umbilical arterial catheter. Singleton or twin birth. no limit no limit Female Requirement for increased ventilator support during the study period. Withdrawal of parental consent. Hemodynamic instability requiring pharmacological intervention. Severe respiratory distress. Infant death during the study period. Requirement for surgical intervention. Discharge from the neonatal unit before completion of the study. Transfer to another healthcare facility or inability to complete follow-up assessments. P07.3 Preterm [premature] newborn [other] Treatment - Other Treatment - Other Control group (Routine Kangaroo Care): Preterm infants will receive skin-to-skin care after stabilization of physiological status, typically initiated approximately 3 days after birth, according to routine clinical practice. In this method, the mother is positioned in a semi-upright sitting posture on a kangaroo mother care (KMC) chair. The infant, wearing only a diaper and a cap, is placed in an upright position—commonly referred to as the “frog position”—on the mother’s chest between the breasts to ensure direct skin-to-skin contact. Intervention group (Immediate Kangaroo Care): Preterm infants will receive early skin-to-skin contact with their mothers within 10 minutes to 24 hours after birth. The infant will be placed directly on the mother’s chest to establish continuous skin-to-skin contact. 1. Respiratory rate. Timepoint: Respiratory rate in both groups is assessed 15 minutes before the start of the intervention and 15 minutes after its initiation, and is continuously monitored throughout the hospitalization period. Method of measurement: Respiratory rate is measured manually over one full minute using a stopwatch (Digikala43hs, China). 2. Arterial oxygen saturation (SpO₂). Timepoint: Arterial oxygen saturation (SpO₂) in both groups is assessed 15 minutes before the start of the intervention and 15 minutes after its initiation, and is continuously monitored throughout the hospitalization period. Method of measurement: Arterial oxygen saturation is measured using a standard patient monitoring system (ARDP Sect Cardia 10, Sa Iran Company). 3. Blood sugar. Timepoint: Blood sugar in both groups is assessed 15 minutes before the start of the intervention and 15 minutes after its initiation, and is continuously monitored throughout the hospitalization period. Method of measurement: Blood glucose is measured using a glucometer (eBsensor, Taiwan) via heel-prick sampling once per shift due to its invasive nature. 4. Time to full nutrition. Timepoint: The time of initiation of oral or breast milk feeding will be recorded after birth. From the start of feeding, infants will be followed continuously during NICU hospitalization until full enteral feeding is achieved. Method of measurement: Nutritional status and attainment of full feeding will be assessed based on gestational age–specific criteria. In infants with gestational age <32 weeks, full feeding is defined as achieving an enteral intake of 150 mL/kg/day. In infants with gestational age 32–37 weeks, attainment of exclusive breastfeeding (BF) is considered as optimal nutrition. 5. Time to ideal weight. Timepoint: Weight is measured daily. Method of measurement: Body weight is measured daily at 9 PM using a digital scale (Taiwan-made, accuracy ±5 g). Measurements are performed with the infant wearing a dry diaper and no clothing. The weight of the diaper is measured separately and subtracted from the total weight to obtain the net body weight. Sepsis. Timepoint: Sepsis will be assessed throughout the hospitalization period, from initiation of the intervention until discharge from the neonatal intensive care unit (NICU) or death of the infant, whichever occurs first. Method of measurement: Sepsis will be diagnosed according to the standard neonatal sepsis criteria routinely used in the neonatal intensive care unit. Diagnosis will be based on the presence of clinical signs documented in the medical record and confirmation by a positive blood culture (BACTEC), as determined by the attending neonatologist. The outcome will be recorded as a dichotomous variable (yes/no). Intracerebral hemorrhage. Timepoint: Intracranial hemorrhage will be assessed from the initiation of the intervention until discharge from the neonatal intensive care unit or death of the infant, whichever occurs first. Method of measurement: Intracranial hemorrhage will be diagnosed based on cranial ultrasonography findings indicating bleeding within the brain and confirmed by a neonatologist. The diagnosis will be documented in the patient's medical record and recorded as a dichotomous variable (yes/no). Necrotizing enterocolitis (NEC). Timepoint: Necrotizing enterocolitis will be assessed daily from the initiation of the intervention until discharge from the neonatal intensive care unit. Method of measurement: Diagnosis based on clinical symptoms and diagnostic findings recorded in the patient's chart including abdominal distension, feeding intolerance, gastric lavage, and diagnosis by a neonatologist. The variable is recorded qualitatively (yes/no). Recording tools include feeding form, lavage form, and abdominal circumference measurement. Neonatal death. Timepoint: Neonatal mortality will be assessed daily from the initiation of the intervention until discharge from the neonatal intensive care unit (NICU) or death of the infant, whichever occurs first. Method of measurement: Neonatal mortality will be determined based on documented death during the hospitalization period and recorded as a dichotomous outcome (yes/no). Shahre-kord University of Medical Sciences Approved 2026-05-17 Research Ethics Committee of Shahrekord and Borujen Faculties of Nursing and Midwifery and School of Building No. 2, University Headquarters, Kashani Boulevard, Shahrekord, Iran. Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)