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IRCT20260318069002N1 IRCT 2026-06-26 Iran University of Medical Sciences The effect of parent education on preterm infant growth Investigating the effect of parent education on communication skills of preterm infants 2026-04-20 anticipated 7 Recruiting https://irct.ir/trial/89364 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance. N/A Condition 1: Preterm infant. Condition 2: Speech and language disorders. Condition 3: Prevention of developmental disorders. Intervention Group: This is a single-subject study consisting of one intervention group. The intervention will be delivered through face-to-face counseling and educational sessions for mothers of preterm infants. The intervention will consist of three individual sessions conducted when the infant is 1 week, 3 months, and 6 months of age. Each session will last approximately 45–60 minutes. Session 1: Mothers will be encouraged to engage in daily skin-to-skin contact with their infant, hold and gently touch the infant, position their face at an appropriate distance from the infant, expose the infant to colorful and sound-producing toys, maintain eye contact with the infant during feeding, smile and talk to the infant, pay attention to signs of hunger and other infant cues and respond promptly to the infant’s needs, use crib mobiles, gently massage the infant’s arms, legs, and body, and sing songs and lullabies to the infant. Session 2: Mothers will be encouraged to imitate the infant’s facial expressions and vocalizations, talk to the infant about daily activities and events, look through picture books and simple illustrated books with the infant and read the stories aloud, use facial expressions that correspond to the content of their speech when interacting with the infant, show the infant his or her reflection in a mirror together with the mother’s reflection, provide supervised tummy time and place toys within the infant’s reach, and repeat simple syllables such as “ba-ba-ba,” “ma-ma-ma,” and “da-da-da” while allowing the infant to observe the mother’s mouth movements. Session 3: Mothers will be encouraged to sing songs and nursery rhymes to the infant, look at picture books and read stories together with the infant, name body parts while simultaneously pointing to the corresponding body parts on themselves and the infant, use toy animals to introduce animal names and sounds while creating simple stories, and engage in ball-playing activities with the infant. Following each intervention session, the educational content will be provided to the mothers in the form of an electronic brochure via the Rubika application to reinforce learning and reduce the likelihood of forgetting the educational materials.. 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 I have not decided yet.
public Zeinab Hedayati abkoohi ravari
School of Rehabilitation Science, Iran University of Medical Science, Madadkaran st, Shahnazari st, Madar sq, Mirdamad Blvd
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2225 6434 zeinab.hedayati.iums1998@gmail.com Iran University of Medical Sciences scientific Maryam Tarameshlu
School of Rehabilitation Science, Iran University of Medical Science, Madadkaran st, Shahnazari st, Madar sq, Mirdamad Blvd
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2225 6434 m.tarameshlu@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Preterm infants with gestational age of maximum 32 weeks at birth Birth weight less than 1500 grams Parental willingness to participate in this study 1 day 10 days Both Medical diseases or special conditions in the newborn; including cardiovascular and respiratory diseases Congenital anomalies or syndromes in the newborn P07 F80 Z13.4 Disorders of newborn related to short gestation and low birth weight, not elsewhere classified Specific developmental disorders of speech and language Encounter for screening for certain developmental disorders in childhood Rehabilitation Intervention Group: This is a single-subject study consisting of one intervention group. The intervention will be delivered through face-to-face counseling and educational sessions for mothers of preterm infants. The intervention will consist of three individual sessions conducted when the infant is 1 week, 3 months, and 6 months of age. Each session will last approximately 45–60 minutes. Session 1: Mothers will be encouraged to engage in daily skin-to-skin contact with their infant, hold and gently touch the infant, position their face at an appropriate distance from the infant, expose the infant to colorful and sound-producing toys, maintain eye contact with the infant during feeding, smile and talk to the infant, pay attention to signs of hunger and other infant cues and respond promptly to the infant’s needs, use crib mobiles, gently massage the infant’s arms, legs, and body, and sing songs and lullabies to the infant. Session 2: Mothers will be encouraged to imitate the infant’s facial expressions and vocalizations, talk to the infant about daily activities and events, look through picture books and simple illustrated books with the infant and read the stories aloud, use facial expressions that correspond to the content of their speech when interacting with the infant, show the infant his or her reflection in a mirror together with the mother’s reflection, provide supervised tummy time and place toys within the infant’s reach, and repeat simple syllables such as “ba-ba-ba,” “ma-ma-ma,” and “da-da-da” while allowing the infant to observe the mother’s mouth movements. Session 3: Mothers will be encouraged to sing songs and nursery rhymes to the infant, look at picture books and read stories together with the infant, name body parts while simultaneously pointing to the corresponding body parts on themselves and the infant, use toy animals to introduce animal names and sounds while creating simple stories, and engage in ball-playing activities with the infant. Following each intervention session, the educational content will be provided to the mothers in the form of an electronic brochure via the Rubika application to reinforce learning and reduce the likelihood of forgetting the educational materials. Infant's communication skills. Timepoint: Data collection will occur at three distinct time points: Baseline assessment: conducted during the first session, prior to the administration of counseling and educational interventions to the mother. Post-intervention assessment I: conducted at the conclusion of the second counseling and education session. Post-intervention assessment II: conducted at the conclusion of the third counseling and education session. Method of measurement: Rosetti infant-toddler scale. Speech and Language Environmental Richness. Timepoint: At the beginning of the intervention (at birth) and then at the end of the intervention. Method of measurement: Speech and Language Environmental Richness Questionnaire. Iran University of Medical Sciences Approved 2025-06-30 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)