Feeding Readiness and Oral Feeding Success in Preterm Infants

NCT04946045 — Not applicable, Completed, 60 participants, Pamukkale University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT04946045
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, supportive care
Enrollment60 (Actual)
SponsorPamukkale University (Other)
ConditionsPreterm, Feeding Behavior, Enteral Feeding Intolerance
InterventionsSensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) (Other)
Datesstart 2020-06-01, primary completion 2020-06-01, completion 2021-06-01, first posted 2021-06-30, last updated 2021-06-30
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Preterm All trials for Feeding Behavior All trials of Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)

-Summary

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

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
İntervention (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) GroupExperimentalOther: Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)1. Tactile/Kinesthetic Stimulation (15 min): It was applied 3 times a day, once every 3 hours for 10 days. 2. Nonnutritive Sucking: It was applied 8 times a day for 10 days with Orogastric (OG) feeding throughout the feeding.
Control (Nonnutritive Sucking) GroupNo intervention1\) Nonnutritive Sucking: Administered during feeding with Orogastric (OG) 8 times a day for 10 days.
  • Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) (Other), also known as Supportive Care: 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".

+Outcome measures

Primary outcomes

  • Oral Feeding Readiness [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

  • Oral Feeding Success [Change in oral feeding success level according to the 12-day six-phase feeding progression protocol]: Six-phase feeding progression protocol

+Eligibility

Sex: All, ages: 30 Weeks to 33 Weeks, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Pamukkale UniversityDenizli, Kınıklı CampusTurkey (Türkiye)

+Investigators

  • Zühal Çamur, RN, PhD, Principal investigator, Pamukkale University