Effect of Breast Milk Olfactory Stimulation (BMOS)

January 8, 2025 updated by: Eman tawfik, Ain Shams University

Effect of Breast Milk Olfactory Stimulation Based Intervention on Preterm Infants' Feeding Outcomes

Breast milk olfactory stimulation will improve preterm infants' outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The researcher will explain the aim of the study and the components of the tools to the studied nurses.

  • The researcher will distribute questionnaire to studied nurses for assessing their knowledge and the researcher will observe their practices regarding breast milk olfactory stimulation for premature infants.
  • The researcher will be divided preterm infant randomly into two equal groups (control and study). While intervention will be directed to study group only before feeding. Both groups will be subjected to same routine care of the NICU.
  • The researcher will be used PIBB scale and neonatal behavioral responses Sheet to assess the premature infants at 1st day of admission as pre intervention after routine care as "change diaper, eye care, cord care, feeding" at morning shift at ten o'clock and one o'clock in the afternoon for study and control group (pre intervention).
  • The researcher will apply breast milk olfactory stimulation technique for study group only before feeding but, both groups will be subjected to same routine care of the NICU.
  • The researcher will assess the effect of used olfactory stimulation technique to study group at 5th and 6th day of admission post intervention.

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: wafaa E ouda, Professor of Pediatric Nursing
  • Phone Number: 01001102693 02
  • Email: drwafaaouda@gmail.com

Study Locations

  • Egypt
      • القاهرة, Egypt, 118111
        • Children's Hospital and Maternity & Gynecological Hospital affiliated to Ain Shams University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Preterm infant has gestational of 30 >37.
  • Birth weight 1000 > 2500 gm.
  • Preterm infant fed oral or gavage feeding or both of them.

Exclusion Criteria:

  • Preterm infants on mechanical ventilation or complicated case

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BMOS technique

The researcher obtained 5cc soaked in a 2cm×2 cm piece of sterilized gauze for every intervention administration.

  • The preterm neonates were positioned in the supine position and the head turned to one side
  • The gauze was placed near the head, 2cm away from the nose for 2 minutes before feeding to stimulate an olfactory sense of preterm neonates 3 times per day (11 am, 2 pm, and 5 pm).
Other: BMOS technique

The researcher obtained 5cc soaked in a 2cm×2 cm piece of sterilized gauze for every intervention administration.

  • The preterm neonates were positioned in the supine position and the head turned to one side
  • The gauze was placed near the head, 2cm away from the nose for 2 minutes before feeding to stimulate an olfactory sense of preterm neonates 3 times per day (11 am, 2 pm, and 5 pm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
enhance preterm infant feeding outcomes
Time Frame: after one week from use breast milk olfactory stimulation
Preterm Neonates Feeding Progression by use (Preterm Infant Breast feeding Behavior Scale .Scoring system. It will be classified into three categories: Low if score (8 to 10), Moderate if score (11 to 16) and Better if score (17 to 20).
after one week from use breast milk olfactory stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • olfactory stimulation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data is available with co responding outers on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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