NCT06771882

Brief Summary

Breast milk olfactory stimulation will improve preterm infants' outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

Same day

First QC Date

January 8, 2025

Last Update Submit

January 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • enhance preterm infant feeding outcomes

    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

Study Arms (1)

BMOS technique

ACTIVE COMPARATOR

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

Interventions

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).

BMOS technique

Eligibility Criteria

Age30 Weeks - 30 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Preterm infants on mechanical ventilation or complicated case

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, 118111, Egypt

Location

Central Study Contacts

Eman T Sayed, master

CONTACT

wafaa E ouda, Professor of Pediatric Nursing

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecture

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 13, 2025

Study Start

February 1, 2025

Primary Completion

February 1, 2025

Study Completion

June 1, 2025

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

data is available with co responding outers on reasonable request

Locations