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Effect of Oral Colostrum Applications Every 2 Hours and 4 Hours In Order to Achieve Trophic Feeding in Preterm Infants

NCT06379178 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-04-23

No results posted yet for this study

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.

Conditions

  • Trophic Feeding
  • Very Low Birth Weight Baby
  • Preterm

Interventions

PROCEDURE

Oral colostrum application 2 hours

Oral colostrum application is an intervention to apply colostrum to oral cavity of subjects. This arm is given oral colostrum application every 2 hours. Colostrum must be from the breastmilk of subject's mother and donor breastmilk is not allowed. Colostrum is treated according to the standard operating procedure of breastmilk storage and preparation of RSUP Dr. Sardjito.

PROCEDURE

Oral colostrum application 4 hours

Oral colostrum application is an intervention to apply colostrum to oral cavity of subjects. This arm is given oral colostrum application every 4 hours. Colostrum must be from the breastmilk of subject's mother and donor breastmilk is not allowed. Colostrum is treated according to the standard operating procedure of breastmilk storage and preparation of RSUP Dr. Sardjito.

Sponsors & Collaborators

  • Gadjah Mada University

    lead OTHER

Principal Investigators

  • Astri T Indriani, Sp.A · Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
2 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-19
Primary Completion
2023-08-15
Completion
2023-08-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06379178 on ClinicalTrials.gov