Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379178
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2024-02-19
Brief Title:
Effect of Oral Colostrum Applications Every 2 Hours and 4 Hours In Order to Achieve Trophic Feeding in Preterm Infants
Sponsor:
Gadjah Mada University
Organization:
Gadjah Mada University
Study Overview
Official Title:
The Effect of Oral Colostrum Applications Every 2 Hours and 4 Hours In Order to Achieve Trophic Feeding in Preterm Infants
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 mothers own breast milk not donors milk and parentsguardians 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 mothers 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 mothers 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 02 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 02 ml using a 1 ml syringe for application to the research subject If stored in the refrigerator rather than the freezer 02 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
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 mothers 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 mothers 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 02 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 02 ml using a 1 ml syringe for application to the research subject If stored in the refrigerator rather than the freezer 02 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None