PIOMI Effects on Preterm Infant Outcomes

NCT07366190 | Completed DMC

• 1 other identifier: NEU-PT2025-04
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Premature Infant Breastfeeding Behavior Scale (PIBBS).

  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

  Change in body weight from baseline to discharge

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

• Length of Hospital Stay

  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

Study Arms (2)

PIOMI

EXPERIMENTAL

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)

Control

OTHER

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

Other: nursing care

Interventions

nursing care OTHER

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

Control

Premature Infant Oral Motor Intervention (PIOMI) OTHER

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.

PIOMI

Eligibility Criteria

• Age: 24 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Konya, 40336, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Weight Gain

Interventions

Nursing Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 26, 2026
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)