Maternal Scent and Preterm Infant Nutrition

Not Applicable

• Conditions: Development, Infant; Development, Child; Behavior, Infant
• Interventions: Other: Maternal scent cloth

• Registration Number: NCT03849248
• Lead Sponsor: American University of Beirut Medical Center

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.

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 Timeline

• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-21
• Study Start: 2019-05-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-05
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• 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

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Exclusion Criteria

• Medically unstable baby born after 36 weeks of gestation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Maternal scent cloth	This group of babies will have a maternal scented cloth placed under their heads

Primary Outcome Measures

Name	Time	Method
Salivary cortisol level	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.

Secondary Outcome Measures

Name	Time	Method
Physiological parameters: Heart rate and respiratory rate	Two years	Infant's heart rate and respiratory rates will be measured.
Achievement of oral feeding	Two years	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.

Trial Locations

Locations (1)

American University of Beirut; 🇱🇧 Beirut, Lebanon