Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04945967 |
| Other study ID # |
21-03-0235 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 13, 2021 |
| Est. completion date |
November 26, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Indonesia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
