Feeding Readiness and Oral Feeding Success in Preterm Infants

NCT04946045 | Completed

• 1 other identifier: Preterm, Feeding Readiness
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preterm; Feeding Behavior; Enteral Feeding Intolerance

Keywords

Preterm; Feeding Readiness; Oral feeding; sensorimotor intervention; neonatal nursing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Oral Feeding Success

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

Study Arms (2)

İntervention (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) Group

EXPERIMENTAL

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.

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

Control (Nonnutritive Sucking) Group

NO INTERVENTION

1\) Nonnutritive Sucking: Administered during feeding with Orogastric (OG) 8 times a day for 10 days.

Interventions

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".

Also known as: Supportive Care

İntervention (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) Group

Eligibility Criteria

• Age: 30 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Kınıklı Campus, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Feeding Behavior

Interventions

Touch; Palliative Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Zühal Çamur, RN, PhD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The "stratified block randomization" method was used to determine which group the preterm infants to be included in the study would be in. Stratification was based on gestational age. The phase of inclusion in the study and control groups was carried out by another investigator in order to avoid study bias with block randomization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD

Model Details: This research is a randomized controlled study with a control group design with pre-test and post-test measurements from experimental research designs.

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 30, 2021
• Study Start: June 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)