Feeding Readiness and Oral Feeding Success in Preterm Infants

Feeding Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04946045
• Other study ID #: Preterm, Feeding Readiness
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2021
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Weeks to 33 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Enteral Feeding Intolerance
• Feeding Behavior
• Premature Birth
• Preterm

Intervention

Other:
• Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)
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".

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli	Kinikli Campus

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Feeding Readiness	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.	10 days change in T-POFRAS (feeding readiness) after sensorimotor intervention.
Secondary	Oral Feeding Success	Six-phase feeding progression protocol	Change in oral feeding success level according to the 12-day six-phase feeding progression protocol