A New Intervention Method to Enhance Oral Feeding Ability in Premature Infants: A Randomized Controlled Trial

NCT04945967 | Completed

• 1 other identifier: 21-03-0235
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Indonesia is the fifth country with the highest number of premature infants in the world. Research has shown that as many as 40% to 70% of premature infants exhibit both immature and atypical feeding skills and those requiring respiratory support and those experiencing delays in beginning oral feeding are most often affected. Majority of premature infants have poorly developed suck and swallow mechanisms. The neurological immaturity, abnormal muscle tone, depressed oral reflexes, and difficulty in regulating state, can decrease the quality of infant's oral motor skills and the quantity of intake. For these reasons many high-risk infants are unable to tolerate oral feeding from birth and have difficulty making the transition from tube feedings to functional oral feeding. This transition to full oral feeding is an important competency for the infant to attain prior to discharge home. Delays in discharge are often secondary to feeding difficulties, leading to increased medical costs. Currently a number of treatment strategies exist to facilitate oral feeding in premature infants. These include environmental/physical modifications such as eliminating external stimuli during feedings, using therapeutic nipples to manipulate flow rate, positioning and swaddling to support the motor system and improve flexion, and oral motor intervention including Non-nutritive sucking (NNS) stimulation and oral/perioral stimulation. There are known various methods of oral and perioral stimulations. Recent study claimed that oral stimulations combined with non-nutritive sucking stimulation in premature infants for at least 10 days period could facilitate oral feeding ability. The therapy of new method intervention that will be studied in this research was a combination of physiological flexion in therapeutic positioning with specific swaddling techniques, oral stimulation, stimulation of synergistic movements, and stimulation of non-nutritive sucking using a special designed pacifier according to the size of premature infant's oral cavity. The objective of this study is to determine the time span required for premature infant to achieve safe and efficient oral feeding after new method intervention. Therefore, this new method expectedly can be used as an intervention to improve oral feeding ability in premature infant.

Conditions

Feeding; Difficult, Newborn; Premature

Keywords

Premature Infant; Oral Feeding Ability; Therapeutic Positioning; Oromotor Intervention

Outcome Measures

Primary Outcomes (2)

• Time Span to Achieve Safe and Efficient Oral Feeding After New Method Intervention

  Time span is measured in days. New method intervention will be given once a day. After New method intervention is done, participant will be evaluated for safe and efficient oral feeding. If the participant has already fulfilled the criteria in safe and efficient oral feeding, intervention will be ended. If participant has not fulfilled the criteria, intervention will be continued.

  1st day after the first session of New method intervention to oral feeding ability achievement

• Time Span to Achieve Safe and Efficient Oral Feeding After Conventional Method Intervention

  Time span is measured in days. Conventional method intervention will be given once a day. After conventional method intervention is done, participant will be evaluated for safe and efficient oral feeding. If the participant has already fulfilled the criteria in safe and efficient oral feeding, intervention will be ended. If participant has not fulfilled the criteria, intervention will be continued.

  1st day after the first session of conventional method intervention to oral feeding ability achievement

Study Arms (2)

New Method

EXPERIMENTAL

This intervention will be given once a day, 30 minutes before feeding schedule based on the neonatologist. Each session of intervention will take time about 18 minutes.

Procedure: New Method

Conventional Method

ACTIVE COMPARATOR

This intervention will be given once a day, 30 minutes before feeding schedule based on the neonatologist. Each session of intervention will take time about 15 minutes.

Procedure: Conventional Method

Interventions

New Method PROCEDURE

Physiological flexion in therapeutic positioning, oral stimulation, stimulation of synergistic movements, and stimulation for non-nutritive sucking by using special designed pacifier for premature infant.

New Method

Conventional Method PROCEDURE

Oral stimulation and non-nutritive sucking stimulation using usual pacifier.

Conventional Method

Eligibility Criteria

• Age: 28 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature infants born 28 to 34 weeks of gestational age
• Has achieved oral feeding readiness in the form of :
• Stable cardiorespiratory status
• Fully feed through orogastric tube of 120ml/kg/day without vomiting or bloating
• Strong and rhythmic non-nutritive sucking (NNS), measured objectively using sucking mechanism evaluation system (5 to 10 non-nutritive sucks per burst, the repetitive pattern was stable, with a pause of 4 to 9 seconds, and the amplitude was -16.7 to -87 mmHg)
• Parent/guardian give consent to participate

You may not qualify if:

• Craniomaxillofacial malformation
• Neonatal asphyxia with 5-minute APGAR score is less than 7
• Grade 3 and 4 intraventricular hemorrhage
• Using endotracheal tube at the time of assessment

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Dr. Cipto Mangunkusumo National General Hospital

Jakarta Pusat, DKI Jakarta, 1358, Indonesia

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Luh K. Wahyuni, MD

  Faculty of Medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Pediatric Physiatrist

Model Details: Premature infants at 28 to 34 weeks of gestational age and has achieved oral feeding readiness but unable to achieve safe and efficient oral feeding will be divided into 2 groups for intervention: New method and conventional method interventions.

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 30, 2021
• Study Start: August 13, 2021
• Primary Completion: November 26, 2021
• Study Completion: November 26, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)