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NCT Number: NCT03371927

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

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.

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Key information

Conditions

Feeding; Difficult, Newborn Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

24 week–33 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University Medical Faculty Hospital

Konya, Selcuklu, 42250, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SINC Feeding Protocol

Other

Safe individualized nipple-feeding competence protocol for premature infants

Primary outcomes

  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 outcomes

  1. Transition to Oral Feeding

    Time frame: from birth to discharge (average 15 weeks)

    time (day) from gavage to full oral feeding

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2017
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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