A New Intervention Method to Enhance Oral Feeding Ability in Premature Infants: A Randomized Controlled Trial
Condition: Feeding; Difficult, Newborn; Premature
MeSH terms: Premature Birth
Study type: Interventional

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.
    

Detailed description: 
      This study was designed as a double-blinded and randomized controlled trial, which was held
      from August 2021 until November 2021 in five tertiary hospitals in Jakarta area: Dr. Cipto
      Mangunkusumo National Central General Hospital, Harapan Kita Women & Children's Hospital,
      Bunda Women & Children's Hospital, Pasar Rebo Regional General Hospital, and Budi Kemuliaan
      General Hospital. Premature infants born in 28-34 weeks who has achieved oral feeding
      readiness but had not achieved oral feeding ability will be recruited as participants.
      Subjects were then randomized and assigned to New method and Conventional method intervention
      groups. The total number of sample size was 70 subjects.

      Both interventions were given once a day, 30 minutes before the infant's feeding schedule.
      After each session of intervention was done, participant will be evaluated for oral feeding
      ability.

      Participant will be in semi-upright position, using peristaltic plus for low-birth-weight
      pacifier in SS size. The volume of fluids feed will be decided based on neonatologist's
      assessment. Participant was stated to achieve oral feeding ability if participant was able to
      swallow more than 30% of the volume set by the neonatologist for the first 5 minutes at a
      rate of more than or equal to 1.5 ml / minute and without signs of aspiration. If the results
      of the evaluation show that the participant has not been able to achieve safe and efficient
      oral feeding, intervention will be terminated. If the participant has not fulfilled the
      criteria, intervention will be continued. However, if the participant became unstable after
      given each intervention, then intervention will be halted and will be repeated again in the
      next feeding schedule. After 3 consecutive trials and the participant is still unstable while
      given intervention, then the participant will be put in drop out category.

      Statistical analysis will be conducted using SPSS ver. 20.0. The level of significance was
      set at <0.05. Interim analysis will be conducted in this research and will be done in three
      steps:

        1. Basic data analysis for comparing distribution between two intervention groups with
           descriptive analysis.

        2. Bivariate analysis using chi-square.

        3. Multivariate analysis using logistic regression if there are incomparable basic data
           variables.
    

Intervention name(s): New Method; Conventional Method
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; Oral stimulation and non-nutritive sucking stimulation using usual pacifier.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Premature Infant; Oral Feeding Ability; Therapeutic Positioning; Oromotor Intervention