Maternal Scent and Preterm Infant Nutrition

April 4, 2022 updated by: Lama Charafeddine, American University of Beirut Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Saadieh Masri, RN
  • Phone Number: 7454 01374444
  • Email: sm52@aub.edu.lb

Study Locations

  • Lebanon
      • Beirut, Lebanon, 1107 2020
        • Recruiting
        • American University of Beirut
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 days to 1 week (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
This group of babies will have a maternal scented cloth placed under their heads
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.
No Intervention: Control
This group of babies will have a clean non- maternal scented cloth placed under their head

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological parameters: Heart rate and respiratory rate
Time Frame: Two years
Infant's heart rate and respiratory rates will be measured.
Two years
Achievement of oral feeding
Time Frame: 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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2019

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (Actual)

February 21, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SBS-2018-0527

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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