Feeding Readiness and Oral Feeding Success in Preterm Infants

The Effect of Sensorimotor Interventions on Feeding Readiness and Oral Feeding Success in Preterm Infants : A Randomized Controlled Study

To examine the effects of sensorimotor interventions applied to in preterm infants on readiness for feeding and oral feeding success.

Study Overview

• Status: Completed
• Conditions: Feeding Behavior; Enteral Feeding Intolerance; Preterm
• Intervention / Treatment: Other: Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)

Detailed Description

The preterm neonate population cannot potentially be fed orally for a long time in the postnatal period. However, the inability of preterm infants to be fed orally as soon as they are born is not a disease, their adaptation to the external environment of the uterus is more complicated because their physiological functions are not yet mature. This also means long hospital stays for premature babies. Therefore, the American Academy of Pediatrics (AAP) has determined that oral feeding is one of the main criteria for the discharge of the preterm infant from the hospital.

Many studies have been conducted on preterm infants on optimizing oral feeding performance. Studies improve oral feeding skills of preterm infants by applying various sensorimotor interventions and cue-based feeding protocols to improve oral feeding performance. These sensorimotor interventions; non-nutritive sucking (pacifier), sucking-swallowing exercises, oral support, oral stimulation, tactile stimulation, kinesthetic stimulation, sound, smell, audio-visual stimulations, etc. methods were used alone or in combination with these methods.

It has been shown in studies that sensorimotor interventions increase the success of oral feeding in preterms, increase the daily feeding volume, increase weight gain, reduce the cost by shortening the hospital stay, shorten the transition time from gastric feeding to oral/breastfeeding and help mother-infant bonding.

This thesis study was conducted using evidence-based interventions that can facilitate the development of oral feeding skills in preterm infants, the feeding problems they encounter, and their transition from gastric feeding to oral feeding.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kınıklı Campus
    • Denizli, Kınıklı Campus, Turkey, 20160
      • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The mother's milk
• Preterm babies with a gestational age of 30-33 weeks
• No facial deformity,
• No respiratory, cardiovascular, gastrointestinal and neurological disorders or syndromes that would prevent or complicate oral feeding,
• No need for oxygen support,
• There will be preterm infants who are not fed orally, but who are started with tube (Orogastric) feeding.

Exclusion Criteria:

• Transferred to another center during the research,
• Unexpected complication development during the research,
• Occurrence of a pathology that will prevent or complicate oral feeding,
• In cases where there is no voluntary consent of the parent
• The mother is Covid positive

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: İntervention (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) Group; Tactile/Kinesthetic Stimulation (15 min): It was applied 3 times a day, once every 3 hours for 10 days.; Nonnutritive Sucking: It was applied 8 times a day for 10 days with Orogastric (OG) feeding throughout the feeding.	Other: Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking); Sensorimotor interventions were applied to in preterm infants between 30-33 weeks of age for 10 days. After that, preterms were included in the "Six-phase feeding progression protocol".; Other Names: Supportive Care
No Intervention: Control (Nonnutritive Sucking) Group; 1) Nonnutritive Sucking: Administered during feeding with Orogastric (OG) 8 times a day for 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Feeding Readiness	Turkish version of the Preterm Oral Feeding Readiness Assessment Scale (T-POFRAS):It was administered to in preterm infants before and after 10 days of intervention by a neonatal nurse independent of the researcher.	10 days change in T-POFRAS (feeding readiness) after sensorimotor intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Feeding Success	Six-phase feeding progression protocol	Change in oral feeding success level according to the 12-day six-phase feeding progression protocol

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Zühal Çamur, RN, PhD, Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Preterm; Feeding Readiness; Oral feeding; sensorimotor intervention; neonatal nursing
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: Preterm, Feeding Readiness

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No