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Efficacy of Premature infant oral motor intervention (PIOMI) on the related muscles in swallowing and its long-term effects on the developmental outcomes of preterm infants with feeding disorders

Efficacy of Premature infant oral motor intervention (PIOMI) on the related muscles in swallowing and its long-term effects on the developmental outcomes of preterm infants with feeding disorders

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250205064649N1
Enrollment
60
Registered
2025-03-01
Start date
2025-04-04
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

preterm infants with feeding disorders. Newborn small for gestational age, 2000-2499 grams

Interventions

Intervention 1: Intervention group: The PIOMI treatment method, the steps of which are explained below, will be implemented for the intervention group by the speech therapist conducting the study wit

Sponsors

University of social welfare and rehabilitation sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Months to 9 Months

Inclusion criteria

Inclusion criteria: gestational age between 28 and 36 weeks at birth who have feeding disorders according to the POFRAS screening test. Infants do not have congenital abnormalities or chromosomal disorders. The presence of physiological stability when providing stimulation, meaning that the stimulation does not cause changes in skin color, heart rate, respiratory rate, or stress in the infant. Infants who do not have or develop chronic medical problems such as bronchopulmonary dysplasia, grade 3 and 4 intraventricular hemorrhage, necrotizing enterocolitis, neonatal asphyxia and seizures, jaundice requiring blood exchange, and sepsis proven by positive blood cultures during or after the treatment period. Apgar score above 6 at the fifth minute after birth Parental consent to participate in the research

Exclusion criteria

Exclusion criteria: If there is an unmanageable risk of harm to the infants Withdrawal or lack of consent from parents to continue the study or transfer of infants to other centers

Design outcomes

Primary

MeasureTime frame
Milk intake: The amount of milk a infant needs in a day. Timepoint: In this study, this variable is measured in the intervention and control groups before and after 7 days of treatment. Method of measurement: In this study, the volume of milk received in the two intervention and control groups before and after treatment with the indicated bottle/syringe will be examined in terms of cc.;Breastfeeding method: The way a infant receives milk during a day. Timepoint: In this study, this variable is measured in the intervention and control groups before and after 7 days of treatment. Method of measurement: Breastfeeding methods will be examined during the evaluation, including breast feeding, bottle feeding, and syringe feeding, before and after treatment in the two intervention and control groups.;Number of days hospitalized: The number of days the infant is recorded in the hospital record from birth until discharge. Timepoint: record from birth until discharge. Method of measurement: The number of days from the start of the intervention to the time of discharge is considered.;Expressive language skills: The ability to create a spoken message in a way that others can understand is called expressive language. Timepoint: Premature infants will be examined at 3 and 6 months (corrected age). Method of measurement: The infant's expressive language skills, such as the ability to produce semivowels, repetitive and non-repetitive babbling, other infant vocalizations, etc., will be assessed based on the Niusha Cognitive, Social Communication, and Movement Development Scale and the Bayley III Infant and Toddler Developmental Scales Diagnostic Test.;Comprehensive language skills: The ability to understand speech, both verbal and nonverbal, is called receptive language. Timepoint: Premature infants will be examined at 3 and 6 months (corrected age). Method of measurement: The infant's receptive language skills, such as understanding emotions, eye contact, involuntary laughter, under

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShamim Ghazi

University of social welfare and rehabilitation sciences

ghazishamim205@gmail.com+98 11 3232 5732

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026