Health Preterm Infants With no Active DiseaseNCT01012505
The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.
An observational study of Health Preterm Infants With no Active Disease and Human Milk Nutrition, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Mammalian fetal sensory development comes in an invariant series, with the tactile/kinesthetic and chemosensory systems the earliest functioning and responsive to stimulation, implicating the importance of these foundational sensory systems for later development. Read more about this study
- Who is it for?
- Ages 7 days to 4 weeks
- Conditions the study is for
- Health Preterm Infants With no Active Disease, Human Milk Nutrition, Incubator Stay
- What is being tested?
- adding pad with maternal milk in hte incubator
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2009to not given
- Phase
- Observational
- 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 7 days to 4 weeks
- All sexes
- No healthy volunteers
- Child
Study population: preterm infants at least 1 weekk of age no active disease or treatment (like respiratory support) place in incubator
Who may be able to join
- preterm infants at least 1 week of age
- no active disease or treatment (like respiratory support)
- place in incubator
Who cannot join
- active disease or treatment
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba medical center
Ramat Gan, 52621
Ayala Maayan-Metzger, Dr., 972-3-5302227, maayan@post.tau.ac.il
About this study
Mammalian fetal sensory development comes in an invariant series, with the tactile/kinesthetic and chemosensory systems the earliest functioning and responsive to stimulation, implicating the importance of these foundational sensory systems for later development. Olfaction is essential for neonatal behavioral adaptation in many mammals, including humans. Experiments show that newborns recognize, and are soothed by, the smell of amniotic fluid. Provision of the mother's smell with breast pads, handkerchiefs she has worn, breast milk on a cotton ball or cotton applicator, or other means of providing odor and taste input can facilitate recognition by the infant's mother at a later time and does not appear to be detrimental to the stability of the infant.
Provision of the odor and taste of the mother's milk has been shown to facilitate the infant's mouthing, sucking, arousal, and calming from irritability, especially in preparation for oral feeding. Using 24 hour monitor analysis and cortisol saliva measurements, we will provide quantitive analysis to the effect of smell.
- Being tested
- adding pad with maternal milk in hte incubator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adding pad with maternal milk in hte incubatorOther
2 days prior to intervention - recording infants data and taking saliva cortisol adding pad with maternal milk - during 2 days - recording infants data and taking saliva cortisol.
stopping intervention and for other 2 days recording infants data and taking saliva cortisol
| Study group | Role | What they receive |
|---|---|---|
| 20 preterm infants | 20 preterm infants without active disease Receives: Other: adding pad with maternal milk in hte incubator |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Preterm Infants With no Active DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012505
- Sponsor's protocol ID
- SHEBA-09-7392-AM-CTIL
- Status last verified
- Nov 2009
- First submitted
- 11 Nov 2009
- Last updated
- 13 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.
- ClinicalTrials.gov ID
- NCT01012505
- Acronym / sponsor ID
- SHEBA-09-7392-AM-CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Tel Aviv University
- Study start
- Dec 2009
- First posted
- 13 Nov 2009 (estimated)
- 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.
Mammalian fetal sensory development comes in an invariant series, with the tactile/kinesthetic and chemosensory systems the earliest functioning and responsive to stimulation, implicating the importance of these foundational sensory systems for later development. Olfaction is essential for neonatal behavioral adaptation in many mammals, including humans. Experiments show that newborns recognize, and are soothed by, the smell of amniotic fluid. Provision of the mother's smell with breast pads, handkerchiefs she has worn, breast milk on a cotton ball or cotton applicator, or other means of providing odor and taste input can facilitate recognition by the infant's mother at a later time and does not appear to be detrimental to the stability of the infant.
Provision of the odor and taste of the mother's milk has been shown to facilitate the infant's mouthing, sucking, arousal, and calming from irritability, especially in preparation for oral feeding. Using 24 hour monitor analysis and cortisol saliva measurements, we will provide quantitive analysis to the effect of smell.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 preterm infants | – | Other: adding pad with maternal milk in hte incubator20 preterm infants without active disease |
Who may qualify
- Ages
- 7 days to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- preterm infants at least 1 weekk of age no active disease or treatment (like respiratory support) place in incubator
Key inclusion criteria (3 listed)
- preterm infants at least 1 week of age
- no active disease or treatment (like respiratory support)
- place in incubator
Key exclusion criteria (1 listed)
- active disease or treatment
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 |
|---|---|---|
| adding pad with maternal milk in hte incubator2 days prior to intervention - recording infants data and taking saliva cortisol adding pad with maternal milk - during 2 days - recording infants data and taking saliva cortisol. stopping intervention and for other 2 days recording infants data and taking saliva cortisol | Other | 20 preterm infants |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2009.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Preterm Infants With no Active Disease and Human Milk Nutrition, run by Sheba Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 13 Nov 2009. 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 Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 Nov 2009.