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PIOMI Effects on Preterm Infant Outcomes

Effects of Premature Infant Oral Motor Intervention (PIOMI) on Feeding Behavior, Weight Gain, and Length of Hospital Stay in Preterm Infants: A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07366190
Enrollment
16
Registered
2026-01-26
Start date
2024-12-01
Completion date
2025-07-01
Last updated
2026-01-26

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

Conditions

Prematurity

Keywords

Premature infant, PIOMI, breastfeeding behavior, weight gain, neonatal intensive care

Brief 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.

Detailed description

Objective This study aimed to investigate the effects of Premature Infant Oral Motor Intervention (PIOMI) on feeding behavior, weight gain, and length of hospital stay in preterm infants hospitalized in the neonatal intensive care unit (NICU). Methods This study was designed as a randomized controlled experimental trial with a pretest-posttest parallel-group design. A total of 32 preterm infants with a gestational age between 26 and 30 weeks were randomly assigned to either the intervention group (n = 16) or the control group (n = 16). The intervention group received Premature Infant Oral Motor Intervention (PIOMI) twice daily for 7 consecutive days (14 sessions in total), while the control group received routine nursing care only. Breastfeeding behavior was assessed using the Premature Infant Breastfeeding Behavior Scale (PIBBS) before and after the intervention. Body weight was measured daily, and total weight gain and length of hospital stay were recorded. Statistical analyses were performed using appropriate parametric and non-parametric tests according to data distribution, with a significance level set at p \< 0.05. Conclusion This study was designed to evaluate the clinical effects of PIOMI on feeding performance, weight gain, and hospitalization outcomes in preterm infants.

Interventions

The Beckman Oral Motor Intervention (BOMI) was redesigned by Dr. Brenda Lessen, modifying its duration and steps, to create the Premature Infant Oral Motor Intervention (PIOMI). PIOMI is the only preterm oral motor intervention that can be consistently and reliably applied and easily taught through a specific training program.In the intervention group, physiotherapists administered PIOMI, which consisted of cheek support, lip rounding, lip closure, gum massage, pressure on the lateral and anterior tip of the tongue, and palate tapping to stimulate sucking. The intervention lasted 3 minutes, followed by 2 minutes of non-nutritive sucking, administered twice daily for 7 consecutive days (each session lasting 5 minutes). Oxygen saturation and heart rate were monitored during the application.

OTHERnursing care

The control group received routine nursing care without any additional oral motor stimulation.

Sponsors

Necmettin Erbakan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This study uses a parallel assignment interventional model. Eligible preterm infants are randomly assigned to either the intervention group receiving Premature Infant Oral Motor Intervention (PIOMI) or to a control group receiving standard care. Both groups are followed concurrently throughout the study period, and outcome measures are assessed at baseline and after the intervention.

Eligibility

Sex/Gender
ALL
Age
24 Weeks to 30 Weeks
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Premature Infant Breastfeeding Behavior Scale (PIBBS).Baseline (pre-intervention) and Day 7 (post-intervention)The PIBBS evaluates six sub-items: latching onto the breast, areola grasp, securing the breast with the mandible, sucking, longest sucking burst, and swallowing. Total scores were documented.The Premature Infant Breastfeeding Behavior Scale (PIBBS) evaluates six sub-items: latching onto the breast, areola grasp, securing the breast with the mandible, sucking, longest sucking burst, and swallowing. The total score ranges from 0 to 20, with higher scores indicating better breastfeeding performance.
discharge weightFrom baseline (pre-intervention) to day 7 after completion of the interventionChange in body weight from baseline to discharge
Length of Hospital StayFrom NICU admission (baseline) until hospital discharge, assessed up to 8 weeksLength of hospital stay is defined as the total number of days from admission to the neonatal intensive care unit (NICU) until hospital discharge.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026