Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in POFRAS Score from Day 1 to Day 14
研究概览
简要总结
This randomized clinical trial aims to evaluate the effectiveness of an oral stimulation program to improve sucking in preterm neonates hospitalized in the NICU. The study compares two groups: one receiving the intervention from a physiotherapist and the other from trained parents. The stimulation program includes 4 extraoral and 4 intraoral exercises applied once daily for 14 consecutive days. The primary outcome is improvement in the POFRAS score. Secondary outcomes include the time to exclusive oral feeding, nasogastric tube withdrawal, weight at discharge, hospital stay duration, and parental adherence. This study addresses the potential role of parent participation in neonatal rehabilitation in public hospitals with limited human resources.
详细描述
This single-blind, randomized clinical trial aims to compare the effectiveness of oral rehabilitation performed by trained parents versus physiotherapists to improve sucking in preterm neonates hospitalized in the NICU at the Hospital Civil de Guadalajara "Fray Antonio Alcalde," during the period July-October 2025.
Eligible neonates will be randomized into two groups:
Group A (Control): Intervention performed daily by a trained physiotherapist.
Group B (Experimental): Intervention performed daily by the parents after structured training and supervised implementation.
The oral stimulation program consists of 4 extraoral and 4 intraoral exercises designed to promote the development of sucking, swallowing, and breathing coordination. Each session lasts approximately 15 minutes and will be applied once daily for 14 consecutive days or until full oral feeding is achieved.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 34 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates with corrected gestational age of 34 to 36 weeks
- •Clinically stable to receive oral stimulation
- •Informed consent obtained from parents or legal guardians
排除标准
- •Orofacial congenital malformations
- •Severe neuromuscular disease
- •Conditions contraindicating oral feeding
研究组 & 干预措施
Parental Oral Stimulation Intervention
Parents are trained to perform a standardized oral stimulation protocol (4 extraoral and 4 intraoral exercises) once daily for 14 days.
干预措施: Parental Oral Stimulation Protocol (Behavioral)
Physiotherapist-led Oral Stimulation
A licensed physiotherapist performs the same standardized oral stimulation protocol once daily for 14 days
干预措施: Physiotherapist-led Oral Stimulation (Behavioral)
结局指标
主要结局
Change in POFRAS Score from Day 1 to Day 14
时间窗: Baseline and Day 14 of intervention
Change in the total score of the POFRAS scale (0-36 points), which evaluates oral feeding readiness in preterm neonates. A higher score indicates greater readiness for oral feeding.
次要结局
- Time to Exclusive Oral Feeding(From baseline to achievement of full oral feeding (up to 14 days))
- Length of Hospital Stay(From birth until hospital discharge, assessed up to 60 days)
- Weight at Hospital Discharge(Baseline and Day 14 post-intervention)
- Parental Satisfaction(At Day 14 or end of intervention)
研究者
Nelsi Alejandra Gonzalez Gonzalez
Physical Medicine and Rehabilitation Physician
Hospital Civil de Guadalajara