Maternal Scent and Preterm Infant Nutrition

Development, Child Clinical Trial

Official title:

The Effect of Maternal Scent on Nutrition and Development of Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03849248
• Other study ID #: SBS-2018-0527
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2019
• Est. completion date: March 1, 2023

Study information

• Verified date: April 2022
• Source: American University of Beirut Medical Center
• Contact: Saadieh Masri, RN
• Phone: 01374444
• Email: sm52[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 10 Days

Eligibility

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

Exclusion Criteria:

• Medically unstable baby born after 36 weeks of gestation.

Related Conditions & MeSH terms

• Behavior, Infant
• Development, Child
• Development, Infant

Intervention

Other:
• Maternal scent cloth
The babies assigned to the intervention group will have a cloth with their mother's scent on it placed under their heads.

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Physiological parameters: Heart rate and respiratory rate	Infant's heart rate and respiratory rates will be measured.	Two years
Secondary	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.	Two years