CompletedNot Applicable

PIOMI Effects on Preterm Infant Outcomes

Turkey (Türkiye)16 participantsStarted 2024-12-01

Plain-language summary

Objective: This study aimed to investigate the effects of Premature Infant Oral Motor Intervention (PIOMI) on body weight gain, breastfeeding behavior, and length of hospital stay in preterm infants hospitalized in the neonatal intensive care unit (NICU). Methods: A randomized controlled experimental study design was used. A total of 32 preterm infants with gestational age between 26-30 weeks were randomly assigned to the intervention group (n=16) or control group (n=16). The intervention group received PIOMI twice daily for 7 consecutive days (14 sessions in total), while the control group received routine care only. The Premature Infant Breastfeeding Behavior Scale (PIBBS) was used to evaluate breastfeeding performance before and after the intervention. Weight changes and length of hospital stay were recorded and compared between groups.

Who can participate

Age range

24 Weeks – 30 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Gestational age between 26 and 30 weeks, * Minimum birth weight of 1350 grams, * Physical stability during oral stimulation, * Apgar score of 4 or above at 5 minutes after birth. Exclusion Criteria: * Presence of congenital anomalies or chromosomal abnormalities, * Chronic medical conditions such as bronchopulmonary dysplasia, * Intraventricular hemorrhage (Grade III or IV), * Necrotizing enterocolitis (NEC), * Asphyxia and seizures, * Treatments related to neonatal jaundice requiring exchange transfusion or blood transfusion, * Sepsis confirmed by positive blood culture.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Premature Infant Breastfeeding Behavior Scale (PIBBS).

Timeframe: Baseline (pre-intervention) and Day 7 (post-intervention)

discharge weight

Timeframe: From baseline (pre-intervention) to day 7 after completion of the intervention

Length of Hospital Stay

Timeframe: From NICU admission (baseline) until hospital discharge, assessed up to 8 weeks

Trial details

NCT IDNCT07366190

SponsorNecmettin Erbakan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-01

View on ClinicalTrials.gov More Prematurity trials