Effect of Breast Milk Olfactory Stimulation

NCT ID: NCT06771882

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-06-01

Brief Summary

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Breast milk olfactory stimulation will improve preterm infants' outcomes.

Detailed Description

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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.

Conditions

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Preterm Infant Feeding Outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

BMOS technique

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Weeks

Maximum Eligible Age

30 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Eman tawfik

assistant lecture

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital and Maternity & Gynecological Hospital affiliated to Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Eman T Sayed, master

Role: CONTACT

02 ext. 01155676323

wafaa E ouda, Professor of Pediatric Nursing

Role: CONTACT

02 ext. 01001102693

Facility Contacts

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Eman T Sayed, master

Role: primary

01155676323 ext. 02

wafaa E Ouda, Professor of Pediatric Nursing

Role: backup

01001102693 ext. 02

Other Identifiers

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olfactory stimulation

Identifier Type: -

Identifier Source: org_study_id

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