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

NCT06379178 | Completed DMC

• 1 other identifier: 6462e56fe8177
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Trophic Feeding; Very Low Birth Weight Baby; Preterm

Keywords

colostrum; very low birth weight; trophic feeding; preterm

Outcome Measures

Primary Outcomes (1)

• Days to Achieve Trophic Feeding

  Days that subjects achieve and tolerate enteral feeding of10cc per kg of body weight/day

  Through study completion, an average of 7 days

Study Arms (2)

Oral Care 2 Hours

ACTIVE COMPARATOR

Oral colostrum application is done every 2 hours

Procedure: Oral colostrum application 2 hours

Oral care 4 Hours

ACTIVE COMPARATOR

Oral colostrum application is done every 4 hours

Procedure: Oral colostrum application 4 hours

Interventions

Oral colostrum application 2 hours PROCEDURE

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.

Oral Care 2 Hours

Oral colostrum application 4 hours PROCEDURE

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.

Oral care 4 Hours

Eligibility Criteria

• Age: Up to 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• infants with gestational age \>34 weeks, birth weight 1000-1500 grams, colostrum used was from the mother's own breast milk (not donor's milk), and parents/guardians were willing to participate in the study

You may not qualify if:

• infants with major congenital abnormalities ( ), infants born to Human Immunodeficiency Virus-positive mother, infants whose mothers consumed breastfeeding contraindicated drug ( ), severely ill mother unable to provide breast milk, and mothers unable to supply breastmilk within 48 hours after delivery

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

Neonatal Intensive Care Unit RSUP Dr. Sardjito

Sleman, Special Region of Yogyakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Astri T Indriani, Sp.A

  Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric neonatology fellow

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: April 23, 2024
• Study Start: February 19, 2023
• Primary Completion: August 15, 2023
• Study Completion: August 31, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals should be directed to tantriindrianiastri@gmail.com To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at (Link to be included).

Locations

ID (1)