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

NCT03371927 | Completed

• 1 other identifier: 12.10.2017/34
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeding; Difficult, Newborn

Keywords

Premature Infants; SINC feeding protocol

Outcome Measures

Primary Outcomes (1)

• Weight Gain

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

  from birth to discharge (average 15 weeks)

Secondary Outcomes (1)

• Transition to Oral Feeding

  from birth to discharge (average 15 weeks)

Other Outcomes (1)

• Length of Hospitalization

  from birth to discharge (average 15 weeks)

Study Arms (2)

Standard Feeding Method

NO INTERVENTION

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

SINC Feeding Protocol

EXPERIMENTAL

Safe individualized nipple-feeding competence (SINC) protocol

Other: SINC Feeding Protocol

Interventions

SINC Feeding Protocol OTHER

Safe individualized nipple-feeding competence protocol for premature infants

SINC Feeding Protocol

Eligibility Criteria

• Age: 24 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Selcuk University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Selcuk University Medical Faculty Hospital

Konya, Selcuklu, 42250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Raziye CELEN, PhD

  Selcuk University

  PRINCIPAL INVESTIGATOR

• Fatma TAS ARSLAN, Ass.Prof.

  Selcuk Universiy

  STUDY DIRECTOR

• Hanifi SOYLU, Prof

  Selcuk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 13, 2017
• Study Start: February 28, 2018
• Primary Completion: March 1, 2019
• Study Completion: July 18, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)