Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age34-36
SponsorHospital Civil de Guadalajara
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Neonates with corrected gestational age of 34 to 36 weeks
Clinically stable to receive oral stimulation
Informed consent obtained from parents or legal guardians
Disqualifiers
Orofacial congenital malformations
Severe neuromuscular disease
Conditions contraindicating oral feeding
Trial design
Design model
Parallel
Treatments tested in this trial
Parental Oral Stimulation Protocol
BehavioralThis intervention consists of a structured oral stimulation protocol composed of 4 extraoral and 4 intraoral exercises designed to improve oral motor function in preterm neonates. Exercises include perioral massage, stimulation of sucking reflex, and non-nutritive sucking using a pacifier. The protocol is administered once daily for 14 consecutive days. In this study arm, the intervention is performed by parents, previously trained and supervised in the neonatal unit.
Physiotherapist-led Oral Stimulation
BehavioralThis intervention consists of a structured oral stimulation protocol composed of 4 extraoral and 4 intraoral exercises designed to improve oral motor function in preterm neonates. Exercises include perioral massage, stimulation of sucking reflex, and non-nutritive sucking using a pacifier. The protocol is administered once daily for 14 consecutive days. In this study arm, the intervention is performed by a licensed physiotherapist.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Parental Oral Stimulation InterventionExperimental treatment 1 intervention
Group B: Physiotherapist-led Oral StimulationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in POFRAS Score from Day 1 to Day 14
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.
Time frame
Baseline and Day 14 of interventionSecondary outcomes
1
Time to Exclusive Oral Feeding
Number of days required for the neonate to transition from tube feeding to exclusive oral feeding without need for nasogastric support.
Time frame
From baseline to achievement of full oral feeding (up to 14 days)2
Weight at Hospital Discharge
Body weight in grams recorded at the time of NICU discharge
Time frame
Baseline and Day 14 post-intervention3
Length of Hospital Stay
Total number of days the neonate remains hospitalized in the neonatal intensive care unit (NICU) until medically cleared for discharge.
Time frame
From birth until hospital discharge, assessed up to 60 days4
Parental Satisfaction
Level of parental satisfaction with the intervention protocol, assessed using a 5-point Likert scale (1 = very dissatisfied; 5 = very satisfied).
Time frame
At Day 14 or end of interventionSponsors and contacts
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Source ClinicalTrials.gov