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IRCT20221206056724N2 IRCT 2026-04-10 Torbate-Heidaria University of Medical Sciences Investigating the Impact of Newborn Care Guidelines on Breastfeeding Indicators Investigating the Impact of Essential Newborn Care Guidelines on Breastfeeding Indicators and Neonatal Outcomes: A Randomized Controlled Trial 2026-03-06 anticipated 70 Complete https://irct.ir/trial/89244 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, a random assignment method using colored cards will be used to divide the research units into two groups: intervention and control. For this purpose, green cards (representing the intervention group) and red cards (representing the control group) will be prepared in equal numbers according to the final sample size and placed in dark, sealed, and opaque envelopes. After each mother meets the entry requirements for the study and obtains informed consent, an envelope will be randomly selected by one of the research assistants who is not involved in the grouping process. The color of the card inside the envelope will determine which group (intervention or control) the research unit will be placed in. This method will continue until the sample size is completed in both groups to ensure a random and balanced distribution of participants in the two groups. N/A Condition 1: Breastfeeding Indicators. Condition 2: Neonatal Outcomes. Intervention 1: Intervention group: A set of interventions initiated at the time of birth in accordance with WHO guidelines and continued for up to 90 minutes after birth or until the completion of the first successful breastfeeding on the mother’s abdomen and chest. These interventions include immediate drying and warming of the newborn on the mother’s abdomen, early and continuous skin-to-skin contact for 90 minutes or until the end of the first successful breastfeeding through the breast crawl method, clamping and cutting of the umbilical cord after cessation of pulsation in the umbilical artery, and guiding the mother to initiate the first breastfeeding via the breast crawl method upon observing early hunger cues. Intervention 2: Control group: Routine ward care, including early clamping of the umbilical cord, skin-to-skin contact for 10 minutes, drying and warming of the newborn under a radiant warmer, and initiation of the first breastfeeding using the conventional method after completion of the third stage of labor and repair of episiotomy and/or any perineal lacerations. Yes - There is a plan to make this available What will be shared: The participants are coded to increase access to them and their information, but at the time of publication, only the result is published and the information of the participants is not published in any way When: 6 months after the results are published To whom: Access is open to the public Conditions: If people have a request, without mentioning the coding and personal information of the people, only the main and secondary outcomes, will be provided to the requester. Where to obtain: E-mail How to obtain: First, the applicant sends a message to the e-mail and explains the reason for using the data, and within a week, the information will be sent to the applicant with conditions and restrictions. Comments:
public Yegane Lagzian
Mehr Boulevard, Valiasr Town
Torbat Heydariyeh Iran (Islamic Republic of) 9516160061 52421000 yegane.lagzian@gmail.com Torbate-Heidaria University of Medical Sciences scientific Yegane Lagzian
Mehr Boulevard, Valiasr Town
Torbat Heydariyeh Iran (Islamic Republic of) 9516160061 52421000 yegane.lagzian@gmail.com Torbate-Heidaria University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Mother's age between 18 and 45 years Gestational age 37 – 42 weeks Vaginal delivery Singleton pregnancy 18 years 45 years Female Mothers with medical and obstetric disorders Mothers with contraindications to breastfeeding Mothers without intention to breastfeeding Mothers with flat or inverted nipples Prevention Prevention Intervention group: A set of interventions initiated at the time of birth in accordance with WHO guidelines and continued for up to 90 minutes after birth or until the completion of the first successful breastfeeding on the mother’s abdomen and chest. These interventions include immediate drying and warming of the newborn on the mother’s abdomen, early and continuous skin-to-skin contact for 90 minutes or until the end of the first successful breastfeeding through the breast crawl method, clamping and cutting of the umbilical cord after cessation of pulsation in the umbilical artery, and guiding the mother to initiate the first breastfeeding via the breast crawl method upon observing early hunger cues. Control group: Routine ward care, including early clamping of the umbilical cord, skin-to-skin contact for 10 minutes, drying and warming of the newborn under a radiant warmer, and initiation of the first breastfeeding using the conventional method after completion of the third stage of labor and repair of episiotomy and/or any perineal lacerations. Baby's behavior at the beginning of breastfeeding. Timepoint: During the first breastfeeding after birth during the intervention. Method of measurement: Infant Breastfeeding Assessment Tool. Breastfeeding self-efficacy. Timepoint: At the time of discharge after the intervention. Method of measurement: Breastfeeding Self-Efficacy Scale-Short Form. Lactogenesis 2. Timepoint: The first time research units feel fullness and firmness in the breasts after giving birth after the intervention. Method of measurement: Lactogenesis 2 Assessment Checklist. Exclusive breastfeeding. Timepoint: At the time of discharge after the intervention. Method of measurement: Exclusive breastfeeding assessment checklist. Neonatal temperature. Timepoint: At 15, 30, 45, 60, 75, 90, 105 and 120 minutes after birth. Method of measurement: mercury thermometer. Neonatal arterial oxygen saturation. Timepoint: At 15, 30, 45, 60, 75, 90, 105 and 120 minutes after birth. Method of measurement: Pulse oximeter device. Neonatal's heartbeat. Timepoint: At 15, 30, 45, 60, 75, 90, 105 and 120 minutes after birth. Method of measurement: Pulse oximeter device. Torbate-Heidaria University of Medical Sciences Approved 2026-02-10 Ethics Committee of Torbat Heydariyeh University of Medical Sciences Mehr Boulevard, Valiasr Town Torbat Heydariyeh Razavi Khorasan Iran (Islamic Republic of)