Effect of SINC Feeding Protocol on Weight Gain, Transition to Oral Feeding and the Length of Hospitalization
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|ClinicalTrials.gov Identifier: NCT03371927|
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : August 5, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Single Blinded|
|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|
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
- 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.
- Transition to Oral Feeding [ Time Frame: from birth to discharge (average 15 weeks) ]time (day) from gavage to full oral feeding
- 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
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
|Selcuk University Medical Faculty Hospital|
|Konya, Selcuklu, Turkey, 42250|
|Principal Investigator:||Raziye CELEN, PhD||Selcuk University|
|Study Director:||Fatma TAS ARSLAN, Ass.Prof.||Selcuk Universiy|
|Study Director:||Hanifi SOYLU, Prof||Selcuk University|