PIOMI Effects on Preterm Infant Outcomes

January 16, 2026 updated by: Neslihan Altuntas Yilmaz, Necmettin Erbakan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Konya
      • Konya, Konya, Turkey (Türkiye), 40336
        • Necmettin Erbakan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PIOMI

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.

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.
Other: Premature Infant Oral Motor Intervention (PIOMI)
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.
Other: Control
The control group received routine nursing care without any additional oral motor stimulation.
Other: nursing care
The control group received routine nursing care without any additional oral motor stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premature Infant Breastfeeding Behavior Scale (PIBBS).
Time Frame: 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.
Baseline (pre-intervention) and Day 7 (post-intervention)
discharge weight
Time Frame: From baseline (pre-intervention) to day 7 after completion of the intervention
Change in body weight from baseline to discharge
From baseline (pre-intervention) to day 7 after completion of the intervention
Length of Hospital Stay
Time Frame: From NICU admission (baseline) until hospital discharge, assessed up to 8 weeks
Length of hospital stay is defined as the total number of days from admission to the neonatal intensive care unit (NICU) until hospital discharge.
From NICU admission (baseline) until hospital discharge, assessed up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Necmettin Erbakan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

July 1, 2025

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEU-PT2025-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to ethical restrictions and the vulnerable nature of the study population (preterm infants). Data contain sensitive clinical information, and sharing individual-level data could compromise participant confidentiality despite anonymization. Therefore, individual patient data will not be made publicly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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