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Analysis of the Effects of Oral Colostrum Administration in Premature Infants on the Breastfeeding

NCT04454502 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2020-07-01

No results posted yet for this study

Summary

In the literature, it is emphasized that oral colostrum administration in very low birth weight infants supported the immune development of the premature newborn, contributed to the development of oral microbiota and reduced the length of hospital stay (Manzoni 2011; Pammi 2011; Zhang 2017; Moreno-Fernandez 2018; Rodriguez 2009). However, there was no source answering the question of how both the mother and the infant are affected by oral colostrum administration in very low birth weight infants. Based on the studies indicating that premature infants distinguished their mother's milk smell and taste (Lecanuet and Schoal, 1996; Aoyama et al. 2010), it was aimed to find answers to the questions of whether this administration in infants without oral intake had positive effect on the success of breastfeeding.

Research Hypotheses:

H0: Oral colostrum administration in very low birth weight premature infants who cannot be fed orally has no effect on breastfeeding.

H1: Oral colostrum administration in very low birth weight premature infants who cannot be fed orally affects the success of breastfeeding

Conditions

  • Oral Colostrum Administration in Very Low Birth Weight Premature Infants

Interventions

OTHER

Oral colostrum administration

In accordance with the oral colostrum protocol, a total of 0.2ml colostrum will be administered into the cheek and on the tongue for the infants weighing between 1001-1500 g.

Sponsors & Collaborators

  • Sakarya University

    lead OTHER

Principal Investigators

  • Dilek Menekşe, PhD · Sakarya University

  • Nursan Cinar, professor · Sakarya University

  • İbrahim Caner, PhD · Sakarya University

  • Özge Karakaya Suzan, MSc · Sakarya University Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-08-01
Completion
2021-08-01

Countries

  • Turkey (Türkiye)

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 NCT04454502 on ClinicalTrials.gov