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PIOMI Effects on Preterm Infant Outcomes

N

Necmettin Erbakan University

Status

Completed

Conditions

Prematurity

Treatments

Other: nursing care
Other: Premature Infant Oral Motor Intervention (PIOMI)

Study type

Interventional

Funder types

Other

Identifiers

NCT07366190
NEU-PT2025-04

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

24 to 30 weeks old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

16 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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