Behavior, InfantNCT03849248
Maternal Scent and Preterm Infant Nutrition
A study testing Maternal scent cloth in people with Behavior, Infant and Development, Infant, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
To study the effect of maternal scent on the oral feeding, behavior and stress level of premature infants hospitalized in the Neonatal intensive care unit and to assess its potential effect on their development at 18 to 24 months. Read more about this study
- Who is it for?
- Ages 5 to 10 daysHealthy volunteers can take part
- Conditions the study is for
- Behavior, Infant, Development, Infant, Development, Child
- What is being tested?
- Maternal scent cloth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteLebanon
- Study dates
- 24 May 2019to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 10 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mother of a baby who was born premature before completing 36 weeks of pregnancy
- Baby between ages of 5-10 days
- Medically stable baby
- Baby already began feeding by mouth or by feeding tube
Who cannot join
- Medically unstable baby born after 36 weeks of gestation.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut
Beirut, 1107 2020
Lama Charafeddine, M.D, lc12@aub.edu.lb
About this study
Official title: The Effect of Maternal Scent on Nutrition and Development of Preterm Infants
To study the effect of maternal scent on the oral feeding, behavior and stress level of premature infants hospitalized in the Neonatal intensive care unit and to assess its potential effect on their development at 18 to 24 months.
Read the detailed description
Premature infants develop their sense of smell very early in the womb. After birth infants can recognize and distinguish the odor of their mother from their father and others. Premature infants are capable of smelling and they experience less pain and agitation when they smell their mother's milk; studies have shown that premature infants have better sucking and feeding, and they may go home earlier when they are exposed to the odor of breast milk. It is not known whether the same will happen if preterm infants are exposed to their mother's smell rather than the smell of the maternal milk.
- Conditions
- Behavior, Infant, Development, Infant, Development, Child
- Being tested
- Maternal scent cloth
- Keywords
- maternal scent, infant behavior, feeding patterns, stress levels
- Medical subject headings
- Infant Behavior, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal scent clothOther
The babies assigned to the intervention group will have a cloth with their mother's scent on it placed under their heads.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group of babies will have a maternal scented cloth placed under their heads Receives: Other: Maternal scent cloth |
| Control | No intervention | This group of babies will have a clean non- maternal scented cloth placed under their head |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol level
The saliva will be collected from infant mouth after enrollment the first day before placing the scented cloth under the infant's head and the second after the exposure to the second cloth.
Levels will be compared before and after and between groups.
Measured: Two years
Secondary outcomes (2)
Physiological parameters: Heart rate and respiratory rate
Infant's heart rate and respiratory rates will be measured.
Measured: Two years
Achievement of oral feeding
The number of days to reach oral feeding of all prescribed feeds will be recorded from the infant medical record, this will be compared between the intervention and control group.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start24 May 2019
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, InfantStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lama Charafeddine, American University of Beirut Medical Center
- Investigators
- Lama Charafeddine, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849248
- Sponsor's protocol ID
- SBS-2018-0527
- Status last verified
- Apr 2022
- First submitted
- 24 Jan 2019
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Maternal Scent on Nutrition and Development of Preterm Infants
- ClinicalTrials.gov ID
- NCT03849248
- Acronym / sponsor ID
- SBS-2018-0527
- Conditions
- Behavior, Infant, Development, Infant, Development, Child
- Keywords
- maternal scent, infant behavior, feeding patterns, stress levels
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 24 May 2019 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 21 Feb 2019 (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.
To study the effect of maternal scent on the oral feeding, behavior and stress level of premature infants hospitalized in the Neonatal intensive care unit and to assess its potential effect on their development at 18 to 24 months.
Detailed description
Premature infants develop their sense of smell very early in the womb. After birth infants can recognize and distinguish the odor of their mother from their father and others. Premature infants are capable of smelling and they experience less pain and agitation when they smell their mother's milk; studies have shown that premature infants have better sucking and feeding, and they may go home earlier when they are exposed to the odor of breast milk. It is not known whether the same will happen if preterm infants are exposed to their mother's smell rather than the smell of the maternal milk.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Maternal scent clothThis group of babies will have a maternal scented cloth placed under their heads |
| Control | No intervention | –This group of babies will have a clean non- maternal scented cloth placed under their head |
Who may qualify
- Ages
- 5 to 10 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Mother of a baby who was born premature before completing 36 weeks of pregnancy
- Baby between ages of 5-10 days
- Medically stable baby
- Baby already began feeding by mouth or by feeding tube
Key exclusion criteria (1 listed)
- Medically unstable baby born after 36 weeks of gestation.
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 |
|---|---|---|
| Maternal scent clothThe babies assigned to the intervention group will have a cloth with their mother's scent on it placed under their heads. | Other | Intervention |
Primary outcome
Salivary cortisol level
Time frame: Two years
The saliva will be collected from infant mouth after enrollment the first day before placing the scented cloth under the infant's head and the second after the exposure to the second cloth. Levels will be compared before and after and between groups.
2 secondary outcomes
Physiological parameters: Heart rate and respiratory rate
Time frame: Two years
Achievement of oral feeding
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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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. This study is not recruiting at the moment.
Lama Charafeddine, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal scent cloth in people with Behavior, Infant and Development, Infant, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 4 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: status not confirmed, as of the sponsor's last update on 5 Apr 2022. 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 Lebanon. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saadieh Masri, RN (01374444 ext. 7454, sm52@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary cortisol level (time frame: Two years). 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 5 Apr 2022.