Skip to main content
OpenTrials
Completed

NCT Number: NCT04946045

Feeding Readiness and Oral Feeding Success in Preterm Infants

To examine the effects of sensorimotor interventions applied to in preterm infants on readiness for feeding and oral feeding success.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 week–33 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, Kınıklı Campus, 20160, Turkey (Türkiye)

About this study

The preterm neonate population cannot potentially be fed orally for a long time in the postnatal period. However, the inability of preterm infants to be fed orally as soon as they are born is not a disease, their adaptation to the external environment of the uterus is more complicated because their physiological functions are not yet mature. This also means long hospital stays for premature babies. Therefore, the American Academy of Pediatrics (AAP) has determined that oral feeding is one of the main criteria for the discharge of the preterm infant from the hospital.

Many studies have been conducted on preterm infants on optimizing oral feeding performance. Studies improve oral feeding skills of preterm infants by applying various sensorimotor interventions and cue-based feeding protocols to improve oral feeding performance. These sensorimotor interventions; non-nutritive sucking (pacifier), sucking-swallowing exercises, oral support, oral stimulation, tactile stimulation, kinesthetic stimulation, sound, smell, audio-visual stimulations, etc. methods were used alone or in combination with these methods.

It has been shown in studies that sensorimotor interventions increase the success of oral feeding in preterms, increase the daily feeding volume, increase weight gain, reduce the cost by shortening the hospital stay, shorten the transition time from gastric feeding to oral/breastfeeding and help mother-infant bonding.

This thesis study was conducted using evidence-based interventions that can facilitate the development of oral feeding skills in preterm infants, the feeding problems they encounter, and their transition from gastric feeding to oral feeding.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The mother's milk
  • Preterm babies with a gestational age of 30-33 weeks
  • No facial deformity,
  • No respiratory, cardiovascular, gastrointestinal and neurological disorders or syndromes that would prevent or complicate oral feeding,
  • No need for oxygen support,
  • There will be preterm infants who are not fed orally, but who are started with tube (Orogastric) feeding.

Exclusion criteria

  • Transferred to another center during the research,
  • Unexpected complication development during the research,
  • Occurrence of a pathology that will prevent or complicate oral feeding,
  • In cases where there is no voluntary consent of the parent
  • The mother is Covid positive

Treatment and study plan

Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)

Other

Sensorimotor interventions were applied to in preterm infants between 30-33 weeks of age for 10 days. After that, preterms were included in the "Six-phase feeding progression protocol".

Other names: Supportive Care

Primary outcomes

  1. Oral Feeding Readiness

    Time frame: 10 days change in T-POFRAS (feeding readiness) after sensorimotor intervention.

    Turkish version of the Preterm Oral Feeding Readiness Assessment Scale (T-POFRAS):It was administered to in preterm infants before and after 10 days of intervention by a neonatal nurse independent of the researcher.

Secondary outcomes

  1. Oral Feeding Success

    Time frame: Change in oral feeding success level according to the 12-day six-phase feeding progression protocol

    Six-phase feeding progression protocol

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

The Effect of Sensorimotor Interventions on Feeding Readiness and Oral Feeding Success in Preterm Infants : A Randomized Controlled Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 30, 2021
Registry last updated
Jun 30, 2021

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.

Published trials that share one or more normalized conditions with this study.