Clinical trial NCT04946045: Feeding Readiness and Oral Feeding Success in Preterm Infants
Official title: The Effect of Sensorimotor Interventions on Feeding Readiness and Oral Feeding Success in Preterm Infants : A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Feeding Behavior
Enteral Feeding Intolerance
Keywords: Preterm
Feeding Readiness
Oral feeding
sensorimotor intervention
neonatal nursing
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research is a randomized controlled study with a control group design with pre-test and post-test measurements from experimental research designs.
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Oral Feeding Readiness
timeFrame: 10 days change in T-POFRAS (feeding readiness) after sensorimotor intervention.
Secondary outcomes:
measure: Oral Feeding Success
timeFrame: Change in oral feeding success level according to the 12-day six-phase feeding progression protocol
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
state: Kınıklı Campus
Study officials:
affiliation: Pamukkale University
name: Zühal Çamur, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: