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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Premature Infant Breastfeeding Behavior Scale (PIBBS).
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Premature Infant Oral Motor Intervention (PIOMI) (Other)
Control
The control group received routine nursing care without any additional oral motor stimulation.
干预措施: nursing care (Other)
结局指标
主要结局
Premature Infant Breastfeeding Behavior Scale (PIBBS).
时间窗: 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 weight
时间窗: From baseline (pre-intervention) to day 7 after completion of the intervention
Change in body weight from baseline to discharge
Length of Hospital Stay
时间窗: 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.
次要结局
未报告次要终点
研究者
Neslihan Altuntas Yilmaz
Principal Investigator
Necmettin Erbakan University