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Nutritive Sucking in Premature Infants

The Comparison Of Effects of Submandibular Stimulation Alone and in Combination with Oral Motor Intervention on Feeding Performance in Preterm Infants: A Single-Blind Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260503069248N1
Enrollment
60
Registered
2026-05-09
Start date
2026-05-22
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Oral feeding disorders in premature infants. Newborn small for gestational age, 1750-1999 grams

Interventions

Intervention 1: Intervention group: Present PIOMI intervention before feeding and for 5 minutes a day for seven consecutive days. Intervention 2: Intervention group:Present PIOMI intervention before f

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Months to 8 Months

Inclusion criteria

Inclusion criteria: Fetal age between 28 and 34 weeks according to the baby's medical record Birth weight between 1000 and 2000 grams Receiving tube feeding and the baby's inability to feed orally Apgar score equal to or greater than 5 in the first 5 minutes recorded in the newborn's medical record No congenital anomalies (such as heart, mouth, etc.) or severe medical problems such as bronchopulmonary dysplasia, grade 3 and 4 intraventricular hemorrhage, necrotizing enterocolitis, and seizures based on the newborn's medical record. Absence of neuropathy based on the infant's medical record No unresolved blood infection based on the newborn's medical record Absence of drug addiction or infectious diseases in mothers of premature infants based on medical records and questions from the mother No open wounds or unhealed wounds on the face and neck area when observing the newborn No history of previous medical procedures

Exclusion criteria

Exclusion criteria: Lack of physiological stability in the onset of nutritional stimuli and changes in the autonomic nervous system (skin color, heart rate below 100 or above 170 and respiratory rate above 70 and SPO2 below 90) Family's unwillingness to continue treatment

Design outcomes

Primary

MeasureTime frame
Premature Oral Feeding Readiness Scale. Timepoint: First, fourth and seventh days of intervention. Method of measurement: Premature Oral Feeding Readiness Scale.

Secondary

MeasureTime frame
Weight gain. Timepoint: First, fourth and seventh days of intervention. Method of measurement: Put the baby on a digital balance and record the baby's weight to gram.;Duration of the hospitalization. Timepoint: First, fourth and seventh days of intervention. Method of measurement: Interval between the first day of preterm infant referral to the NICU until the last day (discharge).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasume Zareei

Ahvaz University of Medical Sciences

Masume.z.96@gmail.com+98 61 3311 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026