Preterm Infant Feeding OutcomesBMOSNCT06771882
Effect of Breast Milk Olfactory Stimulation
A study testing BMOS technique in people with Preterm Infant Feeding Outcomes, run by Ain Shams University at 1 site in Egypt.
Trial summary
Breast milk olfactory stimulation will improve preterm infants' outcomes. Read more about this study
- Who is it for?
- Ages 30 to 30 weeks
- Conditions the study is for
- Preterm Infant Feeding Outcomes
- What is being tested?
- BMOS technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infant has gestational of 30 >37.
- Birth weight 1000 > 2500 gm.
- Preterm infant fed oral or gavage feeding or both of them.
Who cannot join
- Preterm infants on mechanical ventilation or complicated case
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Children's Hospital and Maternity & Gynecological Hospital affiliated to Ain Shams University
Cairo, 118111
Eman T Sayed, master, 01155676323 ext. 02, Dr.eman.tawfik@nursing.asu.edu.eg
wafaa E Ouda, Professor of Pediatric Nursing, 01001102693 ext. 02, drwafaaouda@gmail.com
About this study
Official title: Effect of Breast Milk Olfactory Stimulation Based Intervention on Preterm Infants' Feeding Outcomes
Breast milk olfactory stimulation will improve preterm infants' outcomes.
Read the 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.
- Conditions
- Preterm Infant Feeding Outcomes
- Being tested
- BMOS technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMOS techniqueOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: BMOS technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: after one week from use breast milk olfactory stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Infant Feeding OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman tawfik, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771882
- Sponsor's protocol ID
- olfactory stimulation
- Acronym
- BMOS
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data is available with co responding outers on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breast Milk Olfactory Stimulation Based Intervention on Preterm Infants' Feeding Outcomes
- ClinicalTrials.gov ID
- NCT06771882
- Acronym / sponsor ID
- BMOS / olfactory stimulation
- Conditions
- Preterm Infant Feeding Outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast milk olfactory stimulation will improve preterm infants' outcomes.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| BMOS technique | Active comparator | Other: BMOS techniqueThe 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). |
Who may qualify
- Ages
- 30 to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infant has gestational of 30 >37.
- Birth weight 1000 > 2500 gm.
- Preterm infant fed oral or gavage feeding or both of them.
Key exclusion criteria (1 listed)
- Preterm infants on mechanical ventilation or complicated case
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMOS techniqueThe 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 |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No. data is available with co responding outers on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMOS technique in people with Preterm Infant Feeding Outcomes, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman T Sayed, master (02 ext. 01155676323, Dr.eman.tawfik@nursing.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
enhance preterm infant feeding outcomes (time frame: after one week from use breast milk olfactory stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.