Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03371927
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
The Scientific and Technological Research Council of Turkey
Information provided by (Responsible Party):
Raziye Çelen, Selcuk University

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.


Condition or disease Intervention/treatment Phase
Feeding; Difficult, Newborn Other: SINC Feeding Protocol Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single Blinded
Primary Purpose: Treatment
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
Actual Study Start Date : February 28, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : July 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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




Primary Outcome Measures :
  1. Weight Gain [ Time Frame: from birth to discharge (average 15 weeks) ]
    When babies are discharged from the hospital, researchers look at the nursing evolution sheet, their weight gain (gr) along their hospitalization.


Secondary Outcome Measures :
  1. Transition to Oral Feeding [ Time Frame: from birth to discharge (average 15 weeks) ]
    time (day) from gavage to full oral feeding


Other Outcome Measures:
  1. Length of Hospitalization [ Time Frame: from birth to discharge (average 15 weeks) ]
    When babies are discharged from the hospital, researchers calculate the difference between gestational age (GA) the day they are discharged



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   24 Weeks to 33 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371927


Locations
Layout table for location information
Turkey
Selcuk University Medical Faculty Hospital
Konya, Selcuklu, Turkey, 42250
Sponsors and Collaborators
Selcuk University
The Scientific and Technological Research Council of Turkey
Investigators
Layout table for investigator information
Principal Investigator: Raziye CELEN, PhD Selcuk University
Study Director: Fatma TAS ARSLAN, Ass.Prof. Selcuk Universiy
Study Director: Hanifi SOYLU, Prof Selcuk University
Layout table for additonal information
Responsible Party: Raziye Çelen, Research Assistant, Selcuk University
ClinicalTrials.gov Identifier: NCT03371927    
Other Study ID Numbers: 12.10.2017/34
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raziye Çelen, Selcuk University:
Premature Infants
SINC feeding protocol
Additional relevant MeSH terms:
Layout table for MeSH terms
Weight Gain
Body Weight Changes
Body Weight