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Feeding Readiness and Oral Feeding Success in Preterm Infants

NCT ID: NCT04946045

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-06-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Preterm Feeding Behavior Enteral Feeding Intolerance

Keywords

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Preterm Feeding Readiness Oral feeding sensorimotor intervention neonatal nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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İntervention (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) Group

1. Tactile/Kinesthetic Stimulation (15 min): It was applied 3 times a day, once every 3 hours for 10 days.
2. Nonnutritive Sucking: It was applied 8 times a day for 10 days with Orogastric (OG) feeding throughout the feeding.

Group Type EXPERIMENTAL

Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)

Intervention Type OTHER

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".

Control (Nonnutritive Sucking) Group

1\) Nonnutritive Sucking: Administered during feeding with Orogastric (OG) 8 times a day for 10 days.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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".

Intervention Type OTHER

Other Intervention Names

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Supportive Care

Eligibility Criteria

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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
Minimum Eligible Age

30 Weeks

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Zühal Çamur

RN, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zühal Çamur, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

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Pamukkale University

Denizli, Kınıklı Campus, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Preterm, Feeding Readiness

Identifier Type: -

Identifier Source: org_study_id