Maternal Scent and Preterm Infant Nutrition
The Effect of Maternal Scent on Nutrition and Development of Preterm Infants
1 other identifier
interventional
132
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
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 24, 2019
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedStudy Start
First participant enrolled
May 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedApril 5, 2022
April 1, 2022
3.8 years
January 24, 2019
April 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Two years
Secondary Outcomes (2)
Physiological parameters: Heart rate and respiratory rate
Two years
Achievement of oral feeding
Two years
Study Arms (2)
Intervention
EXPERIMENTALThis group of babies will have a maternal scented cloth placed under their heads
Control
NO INTERVENTIONThis group of babies will have a clean non- maternal scented cloth placed under their head
Interventions
The babies assigned to the intervention group will have a cloth with their mother's scent on it placed under their heads.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Medically unstable baby born after 36 weeks of gestation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
American University of Beirut
Beirut, 1107 2020, Lebanon
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lama Charafeddine, MD
American University of Beirut Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics and Neonatology
Study Record Dates
First Submitted
January 24, 2019
First Posted
February 21, 2019
Study Start
May 24, 2019
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
April 5, 2022
Record last verified: 2022-04