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

Feeding; Difficult, Newborn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371927
• Other study ID #: 12.10.2017/34
• Status: Completed
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: July 18, 2019

Study information

• Verified date: August 2019
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 18, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Weeks to 33 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Feeding; Difficult, Newborn
• Weight Gain

Intervention

Other:
• SINC Feeding Protocol
Safe individualized nipple-feeding competence protocol for premature infants

Locations

Country	Name	City	State
Turkey	Selcuk University Medical Faculty Hospital	Konya	Selcuklu

Sponsors (2)

Lead Sponsor	Collaborator
Selcuk University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	Transition to Oral Feeding	time (day) from gavage to full oral feeding	from birth to discharge (average 15 weeks)