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Feeding Readiness and Oral Feeding Success in Preterm Infants

Primary Purpose

Preterm, Feeding Behavior, Enteral Feeding Intolerance

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm focused on measuring Preterm, Feeding Readiness, Oral feeding, sensorimotor intervention, neonatal nursing

Eligibility Criteria

30 Weeks - 33 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

İntervention (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) Group

Control (Nonnutritive Sucking) Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Oral Feeding Success
Six-phase feeding progression protocol

Full Information

First Posted
June 23, 2021
Last Updated
June 23, 2021
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04946045
Brief Title
Feeding Readiness and Oral Feeding Success in Preterm Infants
Official Title
The Effect of Sensorimotor Interventions on Feeding Readiness and Oral Feeding Success in Preterm Infants : A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm, Feeding Behavior, Enteral Feeding Intolerance
Keywords
Preterm, Feeding Readiness, Oral feeding, sensorimotor intervention, neonatal nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
İntervention (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (Nonnutritive Sucking) Group
Arm Type
No Intervention
Arm Description
1) Nonnutritive Sucking: Administered during feeding with Orogastric (OG) 8 times a day for 10 days.
Intervention Type
Other
Intervention Name(s)
Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)
Other Intervention Name(s)
Supportive Care
Intervention Description
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".
Primary Outcome Measure Information:
Title
Oral Feeding Readiness
Description
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.
Time Frame
10 days change in T-POFRAS (feeding readiness) after sensorimotor intervention.
Secondary Outcome Measure Information:
Title
Oral Feeding Success
Description
Six-phase feeding progression protocol
Time Frame
Change in oral feeding success level according to the 12-day six-phase feeding progression protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zühal Çamur, RN, PhD
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
State/Province
Kınıklı Campus
ZIP/Postal Code
20160
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Feeding Readiness and Oral Feeding Success in Preterm Infants

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