Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06379178 |
| Other study ID # |
6462e56fe8177 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 19, 2023 |
| Est. completion date |
August 31, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Gadjah Mada University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is aims to evaluate the effects of applying colostrum orally
every 4 and 2 hours in order to achieve trophic feeding in preterm infants. The main question
it aims to answer is the optimal frequency of colostrum application that can be applied
Participants will be divided by randomization using permutation blocks after meeting the
inclusion and exclusion criteria and deemed eligible. These blocks were then randomized using
computer software such as Microsoft Excel, determining the sequence for allocation to the
control and intervention groups based on the randomization order from the permutation code,
every 2 hours and every 4 hours. Researchers will investigate the effects of oropharyngeal
colostrum application frequency, every 4 hours and every 2 hours, in order to achieve trophic
feeding in preterm infants <34 weeks gestational age.
Description:
This study is an experimental research using an open-label Randomized Controlled Trial (RCT)
design for a comparative analysis to investigate the effects of oropharyngeal colostrum
application frequency, every 4 hours and every 2 hours, in order to achieve trophic feeding
in preterm infants <34 weeks gestational age. Inclusion criteria include infants with
gestational age <34 weeks, birth weight between 1000-1500 grams, colostrum used was from the
mother's own breast milk (not donors' milk), and parents/guardians were willing to
participate in the study by signing informed consent. The exclusion criteria involved infants
with major congenital abnormalities, infants born to Human Immunodeficiency Virus-positive
mothers, infants whose mothers consumed breastfeeding contraindicated drugs, severely ill
mothers unable to provide breast milk, and mothers unable to supply breast milk within 48
hours after delivery. The research was conducted after obtaining approval from the Ethics
Committee of the Faculty of Medicine, Public Health, and Nursing, UGM, with approval number
KE-FK-0811-EC-202.
The sample size was determined using the formula for the independent t-test, requiring a
minimum of 14 samples in each group, totaling 28. To account for potential loss to follow-up,
the researcher added 10% more samples, resulting in a minimum total of 32 samples. Samples
meeting the inclusion and exclusion criteria and deemed eligible underwent randomization
using permutation blocks. These blocks were then randomized using computer software such as
Microsoft Excel, determining the sequence for allocation to the control and intervention
groups based on the randomization order from the permutation code.
The instruments used in this study were the Electronic Medical Record (EMR) from the research
subjects and the Case Report Form (CRF). The study necessitated colostrum from the mother's
own breast milk, a 1 ml syringe to measure colostrum volume, a tool to facilitate even
colostrum application, and a suction catheter to remove excess saliva. The independent
variable was the frequency of colostrum application with a categorical variable scale. The
dependent variable was the time to achieve trophic feeding with a numerical variable scale,
while external variables include necrotizing enterocolitis, sepsis, hsPDA, and gender,
represented as categorical variables.
Breast milk expression was initiated within 6 hours post-delivery, adjusted based on the
mother's condition. Nurses or doctors assisted with the initial breast milk expression using
standard hospital-grade breast pumps or manual methods. Expression was performed by the
mother or with the assistance of her spouse every 2-3 hours (eight times per day), with a
minimum duration of 10 minutes on each breast. The expressed breast milk was collected in a
container, drawn into a 1 ml, 3 ml, or 5 ml syringe depending on the obtained volume, and
then labeled for identification. For colostrum application, the nurse took 0.2 ml of
colostrum using a 1 ml syringe. Colostrum application prioritized the freshest breast milk,
allowing direct administration to the research subject. The remaining breast milk can be used
within 2-4 hours at room temperature (16-29 °C) or stored in the refrigerator or freezer
according to breast milk storage standards. If frozen, the breast milk should be thawed in
the refrigerator before being extracted in the amount of 0.2 ml using a 1 ml syringe for
application to the research subject. If stored in the refrigerator, rather than the freezer,
0.2 ml of breast milk should be drawn with a 1 ml syringe, allowed to sit for a designated
period (15-30 minutes), and subsequently administered to the research subject.
The administration and preparation of colostrum were performed by a nurse. The nurse
conducted an analysis beforehand, following the pre-procedure checklist for colostrum
application in the Neonatal Intensive Care Unit (NICU) for each research subject scheduled
for colostrum application. If the research subject used mechanical ventilation, the colostrum
application procedure was carried out by 2 nurses. Before colostrum application, the oral
cavity of the research subject was examined. If excess fluid or saliva was found, suction was
performed first, or a sterile gauze was used to remove excess fluid while eliminating dry
skin or debris on the lips. Then, with the aid of a 1 ml syringe, colostrum was evenly
applied to both right and left cheeks (buccal mucosa), the roof of the mouth, gingival
surface, and lips for approximately 1-2 minutes every 2 hours (12 times per day) and every 4
hours (6 times per day). Colostrum in the mouth will be distributed as it mixes with saliva.
Colostrum application to the mouth began within 24-48 hours after birth and continued for a
total of 5 days.
For research subjects experiencing clinically unstable conditions such as apnea, tachypnea,
or desaturation, stabilization was carried out first following the Neonatal Intensive Care
Unit (NICU) RSUP Dr. Sardjito Standard Operational Procedure (SOP). After stabilization,
colostrum application can be resumed. In cases of feeding intolerance, management was carried
out according to the SOP for handling feeding intolerance. If breast milk is available and
there are no contraindications to enteral feeding, it can be administered promptly.
Observations of subjects were recorded using the NICU daily monitoring sheet, with detailed
notes on various evaluations such as age, days of care, vital signs, feeding intolerance,
diagnosis, fluid balance, diuresis, and so forth. Primary research data came from the Case
Report Form (CRF) based on the Electronic Medical Record (EMR) and the daily monitoring form
in the NICU. The research subjects were prospectively observed, with data being regularly
monitored every day until the primary outcomes were achieved, with a maximum observation
period of 21 days.
