Maternal Scent and Preterm Infant Nutrition

Study Overview
=================
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.

Official Title
-----------------
The Effect of Maternal Scent on Nutrition and Development of Preterm Infants

Conditions
-----------------
Behavior, Infant, Development, Infant, Development, Child

Intervention / Treatment
-----------------
* Other: Maternal scent cloth


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Days
Maximum Age: 10 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This group of babies will have a maternal scented cloth placed under their heads | Other: Maternal scent cloth<br>* The babies assigned to the intervention group will have a cloth with their mother's scent on it placed under their heads.<br>|
| No Intervention: Control<br>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 | 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 | Infant's heart rate and respiratory rates will be measured. | Two years | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
maternal scent, infant behavior, feeding patterns, stress levels