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Effect of SINC Feeding Protocol on Weight Gain, Transition to Oral Feeding and the Length of Hospitalization

Primary Purpose

Feeding; Difficult, Newborn

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
SINC Feeding Protocol
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding; Difficult, Newborn focused on measuring Premature Infants, SINC feeding protocol

Eligibility Criteria

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

Inclusion Criteria:

Having been born between 24-33+6 weeks of gestational age 28-33+6 postmenstrual weeks Monitoring with the diagnosis of healthy preterm infants

Exclusion Criteria:

  • Receiving mechanical ventilation
  • Congenital anomalies
  • Having a surgical operation
  • Having serious health problems

Sites / Locations

  • Selcuk University Medical Faculty Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Feeding Method

SINC Feeding Protocol

Arm Description

The control group consisted of prescribed volumes of oral and/or gavage feedings at two or three hour intervals per feeding.

Safe individualized nipple-feeding competence (SINC) protocol

Outcomes

Primary Outcome Measures

Weight Gain
When babies are discharged from the hospital, researchers look at the nursing evolution sheet, their weight gain (gr) along their hospitalization.

Secondary Outcome Measures

Transition to Oral Feeding
time (day) from gavage to full oral feeding

Full Information

First Posted
November 30, 2017
Last Updated
August 1, 2019
Sponsor
Selcuk University
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT03371927
Brief Title
Effect of SINC Feeding Protocol on Weight Gain, Transition to Oral Feeding and the Length of Hospitalization
Official Title
Effect of SINC Feeding Protocol on Weight Gain, Transition to Oral Feeding and the Length of Hospitalization in Premature Infants: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
July 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
Collaborators
The Scientific and Technological Research Council of Turkey

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
Feeding is one of the most common problems encountered by preterm infants. Besides, effective and safe feeding is one of the important discharge criteria. Feeding problems of premature infants lead to prolonged hospitalization and increased healthcare cost. SINC feeding protocol was developed based on evidence-based feeding protocol (such as cue-based, infant-driven feeding) and individualized developmental care. The aim of the study is to determine the effect of the SINC feeding protocol on weight gain, transition to oral feeding and the length of hospitalization in premature infants according to traditional feeding method. Randomized controlled study, including 30 infants of 28-33+6 weeks gestation receiving either Standard Feeding or SINC Feeding Protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding; Difficult, Newborn
Keywords
Premature Infants, SINC feeding protocol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single Blinded
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Feeding Method
Arm Type
No Intervention
Arm Description
The control group consisted of prescribed volumes of oral and/or gavage feedings at two or three hour intervals per feeding.
Arm Title
SINC Feeding Protocol
Arm Type
Experimental
Arm Description
Safe individualized nipple-feeding competence (SINC) protocol
Intervention Type
Other
Intervention Name(s)
SINC Feeding Protocol
Intervention Description
Safe individualized nipple-feeding competence protocol for premature infants
Primary Outcome Measure Information:
Title
Weight Gain
Description
When babies are discharged from the hospital, researchers look at the nursing evolution sheet, their weight gain (gr) along their hospitalization.
Time Frame
from birth to discharge (average 15 weeks)
Secondary Outcome Measure Information:
Title
Transition to Oral Feeding
Description
time (day) from gavage to full oral feeding
Time Frame
from birth to discharge (average 15 weeks)
Other Pre-specified Outcome Measures:
Title
Length of Hospitalization
Description
When babies are discharged from the hospital, researchers calculate the difference between gestational age (GA) the day they are discharged
Time Frame
from birth to discharge (average 15 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Having been born between 24-33+6 weeks of gestational age 28-33+6 postmenstrual weeks Monitoring with the diagnosis of healthy preterm infants Exclusion Criteria: Receiving mechanical ventilation Congenital anomalies Having a surgical operation Having serious health problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raziye CELEN, PhD
Organizational Affiliation
Selcuk University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatma TAS ARSLAN, Ass.Prof.
Organizational Affiliation
Selcuk Universiy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hanifi SOYLU, Prof
Organizational Affiliation
Selcuk University
Official's Role
Study Director
Facility Information:
Facility Name
Selcuk University Medical Faculty Hospital
City
Konya
State/Province
Selcuklu
ZIP/Postal Code
42250
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of SINC Feeding Protocol on Weight Gain, Transition to Oral Feeding and the Length of Hospitalization

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