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Effectiveness of Oral Immunotherapy Among Preterm Babies

NCT03633500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-07-12

No results posted yet for this study

Summary

The aim of the study is to assess the effectiveness of OIT with colostrum on the feeding behavior and Clinical Outcome of Late-onset sepsis and Necrotizing enterocolitis

Conditions

  • Feeding Behavior
  • Late-Onset Neonatal Sepsis

Interventions

OTHER

Sterile water

Placebo Comparator: Sterile water: 0.2 ml of sterile water is instilled into the posterior buccal cavity in aliquots of 0.1 ml over a 30 second period. The liquid is given time to get absorbed, any pooled liquid is swabbed in the infants' cheek and gum. This is performed every 4 hours until independent safe cup feeds, breastfeed or bottle feed is established consistently for 48 hours.

BIOLOGICAL

Breastmilk

Experimental: Breastmilk: 0.2 ml of mothers' own colostrum/ breast milk is instilled into the posterior buccal cavity in aliquots of 0.1 ml over a 30 second period. The colostrum is given time to get absorbed, any pooled milk is swabbed in the infants' cheek and gum. This is performed every 4 hours until independent safe cup feeds, breastfeed or bottle feed is established consistently for 48 hours. independently sucks at breast, bottle or cup feed

Sponsors & Collaborators

  • Al Adan Hospital Kuwait

    lead INDUSTRY

Principal Investigators

  • Shiney Easo, masters · AL Adan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-16
Primary Completion
2018-12-28
Completion
2018-12-28

Countries

  • Kuwait

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 NCT03633500 on ClinicalTrials.gov