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

NCT ID: NCT03371927

Last Updated: 2019-08-05

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

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-28

Study Completion Date

2019-07-18

Brief Summary

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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.

Detailed Description

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Conditions

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Feeding; Difficult, Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single Blinded

Study Groups

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Standard Feeding Method

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

Group Type NO_INTERVENTION

No interventions assigned to this group

SINC Feeding Protocol

Safe individualized nipple-feeding competence (SINC) protocol

Group Type EXPERIMENTAL

SINC Feeding Protocol

Intervention Type OTHER

Safe individualized nipple-feeding competence protocol for premature infants

Interventions

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SINC Feeding Protocol

Safe individualized nipple-feeding competence protocol for premature infants

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Raziye Çelen

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raziye CELEN, PhD

Role: PRINCIPAL_INVESTIGATOR

Selcuk University

Fatma TAS ARSLAN, Ass.Prof.

Role: STUDY_DIRECTOR

Selcuk Universiy

Hanifi SOYLU, Prof

Role: STUDY_DIRECTOR

Selcuk University

Locations

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Selcuk University Medical Faculty Hospital

Konya, Selcuklu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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12.10.2017/34

Identifier Type: -

Identifier Source: org_study_id

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