The effect of the combination of submandibular stimulations and preterm infant oral motor intervention on feeding function of premature infants with feeding problems hospitalized in the NICU

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240629062279N1

Enrollment

Registered

2024-08-25

Start date

2024-07-22

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Preterm Infant with feeding problems.

Interventions

Intervention 1: Intervention group: Intervention group: Premature infants at 29-33 weeks will receive the PIOMI intervention for 10 consecutive days in the same way as the first group (control). After

Eligibility

Sex/Gender

All

Age

7 Days to 28 Days

Inclusion criteria

Inclusion criteria: Fetal age between 29 and 33 weeks according to the first trimester ultrasound and clinical examinations Birth weight between 1000 and 2000 grams Tube feeding and inability of the infant to feed orally Apgar score equal to or greater than 8 recorded in the neonatal medical record Absence of congenital anomalies (such as heart, mouth, etc.) or severe medical problems such as bronchopulmonary dysplasia, grade 3 and 4 intraventricular hemorrhage, gastrointestinal necrosis, according to the case Neonatal Medicine No neuropathy based on the baby's medical record No unresolved blood infection based on the baby's medical record

Exclusion criteria

Exclusion criteria: Physiological instability in the onset of nutritional stimuli and changes in the autonomic nervous system (skin color, heart rate, and respiratory rate) Unwillingness of the family to continue treatment

Design outcomes

Primary

Measure	Time frame
Duration of transition from gavage to full oral feeding. Timepoint: Last day of treatment. Method of measurement: Counting the number of days from the time of gavage to reaching full oral feeding( day).;Premature Infant Oral Feeding Readiness Assessment Index Score(POFRAS). Timepoint: Before the start of the study and the fifth and tenth days. Method of measurement: POFRAS Questionnaire Score Score (0-2 for each item and maximum score of 36).;Non-nutritious sucking index score. Timepoint: Before the start of the study and the fifth and tenth days. Method of measurement: Using the NNS questionnaire /Grade (minimum score of -21 and maximum of 86).	—

Measure

Time frame

Duration of transition from gavage to full oral feeding. Timepoint: Last day of treatment. Method of measurement: Counting the number of days from the time of gavage to reaching full oral feeding( day).;Premature Infant Oral Feeding Readiness Assessment Index Score(POFRAS). Timepoint: Before the start of the study and the fifth and tenth days. Method of measurement: POFRAS Questionnaire Score Score (0-2 for each item and maximum score of 36).;Non-nutritious sucking index score. Timepoint: Before the start of the study and the fifth and tenth days. Method of measurement: Using the NNS questionnaire /Grade (minimum score of -21 and maximum of 86).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Trameshlu

Iran University of Medical Sciences

m.tarameshlu@gmail.com+98 21 2222 2059

Outcome results

None listed

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