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

Effect of SINC Feeding Protocol on Weight Gain, Transition to Oral Feeding and the Length of Hospitalization in Premature Infants: Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Feeding; Difficult, Newborn
• Intervention / Treatment: Other: SINC Feeding Protocol

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Selcuklu
    • Konya, Selcuklu, Turkey, 42250
      • Selcuk University Medical Faculty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Feeding Method; The control group consisted of prescribed volumes of oral and/or gavage feedings at two or three hour intervals per feeding.
Experimental: SINC Feeding Protocol; Safe individualized nipple-feeding competence (SINC) protocol	Other: SINC Feeding Protocol; Safe individualized nipple-feeding competence protocol for premature infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transition to Oral Feeding	time (day) from gavage to full oral feeding	from birth to discharge (average 15 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospitalization	When babies are discharged from the hospital, researchers calculate the difference between gestational age (GA) the day they are discharged	from birth to discharge (average 15 weeks)

Collaborators and Investigators

• Sponsor: Selcuk University
• Collaborators: The Scientific and Technological Research Council of Turkey
• Investigators: Principal Investigator: Raziye CELEN, PhD, Selcuk University; Study Director: Fatma TAS ARSLAN, Ass.Prof., Selcuk Universiy; Study Director: Hanifi SOYLU, Prof, Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): July 18, 2019

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Premature Infants; SINC feeding protocol
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: 12.10.2017/34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No