Feeding Readiness and Oral Feeding Success in Preterm Infants

Sponsor

Pamukkale University (Other)

Overall Status

Completed

CT.gov ID

NCT04946045

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Preterm Feeding Behavior Enteral Feeding Intolerance	Other: Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This research is a randomized controlled study with a control group design with pre-test and post-test measurements from experimental research designs.This research is a randomized controlled study with a control group design with pre-test and post-test measurements from experimental research designs.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The "stratified block randomization" method was used to determine which group the preterm infants to be included in the study would be in. Stratification was based on gestational age. The phase of inclusion in the study and control groups was carried out by another investigator in order to avoid study bias with block randomization.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 1, 2020

Actual Primary Completion Date :

Jun 1, 2020

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Oral Feeding Readiness [10 days change in T-POFRAS (feeding readiness) after sensorimotor intervention.]
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.

Secondary Outcome Measures

Oral Feeding Success [Change in oral feeding success level according to the 12-day six-phase feeding progression protocol]
Six-phase feeding progression protocol

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Weeks to 33 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pamukkale University	Denizli	Kınıklı Campus	Turkey	20160

Sponsors and Collaborators

Pamukkale University

Investigators

Principal Investigator: Zühal Çamur, RN, PhD, Pamukkale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zühal Çamur, RN, PhD, Pamukkale University

ClinicalTrials.gov Identifier:

NCT04946045

Other Study ID Numbers:

Preterm, Feeding Readiness

First Posted:

Jun 30, 2021

Last Update Posted:

Jun 30, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zühal Çamur, RN, PhD, Pamukkale University

Preterm

Feeding Readiness

Oral feeding

sensorimotor intervention

neonatal nursing

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Jun 30, 2021