Maternal Scent and Preterm Infant Nutrition

NCT ID: NCT03849248

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-24
• Study Completion Date: 2023-03-01

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.

Conditions

Behavior, Infant; Development, Infant; Development, Child

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Intervention

This group of babies will have a maternal scented cloth placed under their heads

Group Type: EXPERIMENTAL

Maternal scent cloth

Intervention Type: OTHER

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

Control

This group of babies will have a clean non- maternal scented cloth placed under their head

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Days
• Maximum Eligible Age: 10 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Lama Charafeddine

Associate Professor of Pediatrics and Neonatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lama Charafeddine, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

American University of Beirut

Beirut, , Lebanon

Site Status: RECRUITING

Countries

Lebanon

Central Contacts

Saadieh Masri, RN

Role: CONTACT

sm52@aub.edu.lb

01374444 ext. 7454

Facility Contacts

Lama Charafeddine, M.D

Role: primary

lc12@aub.edu.lb

Other Identifiers

SBS-2018-0527

Identifier Type: -

Identifier Source: org_study_id