Development, Infant Clinical Trial
Official title:
The Effect of Maternal Scent on Sleep Wake States, Brain Maturation, and Heart Rate Variability: A Randomized Controlled Trial
NCT number | NCT04301453 |
Other study ID # | AAAS5200 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 30, 2019 |
Est. completion date | May 27, 2021 |
Verified date | August 2022 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will be a prospective, randomized controlled study, which aims to determine if a maternal scent intervention improves the sleep wake states, brain maturation, and heart rate variability in premature infants admitted to the neonatal intensive care unit (NICU). Infants will be randomized to either 24 hours of exposure to maternal scent or standard of care. Sleep wake states will be obtained using behavioral coding. Brain maturation will be measured using several electroencephalogram (EEG) parameters. Heart rate variability will be collected as part of vital sign collection.
Status | Completed |
Enrollment | 78 |
Est. completion date | May 27, 2021 |
Est. primary completion date | May 27, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Weeks to 36 Weeks |
Eligibility | Inclusion criteria: - Infants born at 30 weeks gestation to 36 weeks gestation. Exclusion criteria: - Infants with congenital anomalies, neonatal abstinence syndrome, or head ultrasound findings of grade II intraventricular hemorrhage or greater. - Infants participating in studies with similar interventions. |
Country | Name | City | State |
---|---|---|---|
United States | New York Presbyterian, Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of time spent in quiet sleep | Active sleep, quiet sleep, and indeterminate sleep will be behaviorally coded to determine the total amount of time spent in quiet sleep. | 2 hours | |
Primary | Percentage of time spent active sleep | Active sleep, quiet sleep, and indeterminate sleep will be behaviorally coded to determine the total amount of time spent in active sleep. | 2 hours | |
Secondary | Beta to theta ratio | EEG data will be analyzed to determine the beta to theta ratio in order to assess sleep wake cycling. | 2 hours | |
Secondary | Number of mothers diagnosed with acute stress disorder based on score on the Stanford Acute Stress Reaction Questionnaire (SASRQ) | The SASRQ questionnaire is used to assess symptoms of stress after a difficult event. There are four sub-scales including 1) Dissociative Symptoms 2) Re-Experiencing 3) Avoidance and 4) Increased Anxiety. These sub-scales are scored to determine if the diagnosis of acute stress disorder can be made. A symptom is scored as present if the respondent marks it as occurring at least "sometimes," which includes a response of 3, 4 or 5 on the 0-5 scale. A diagnosis of Acute Stress Disorder requires at least 3 symptoms out of the five types of dissociative symptoms, 1 reexperiencing symptom, 1 avoidance symptom, and 1 marked anxiety/increased arousal symptom. In order to count a symptom as present, circled response must be 3 or higher. | 2 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05412524 -
Impact of Reading on Endogenous Oxytocin System of Preterm Infants
|
N/A | |
Active, not recruiting |
NCT03506971 -
Early Childhood : Action Research in the Lunévillois Area (PERL)
|
N/A | |
Not yet recruiting |
NCT06377098 -
Intrapartum Sildenafil in Laboring Mothers
|
Phase 2 | |
Terminated |
NCT04436055 -
Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)
|
||
Recruiting |
NCT05527080 -
Development of Motility and Cognition in Infants
|
||
Not yet recruiting |
NCT05901766 -
Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment
|
Phase 4 | |
Not yet recruiting |
NCT06396520 -
Neuroimaging of Babies During Natural Sleep to Assess Typical Development and Cerebral Palsy
|
||
Recruiting |
NCT05230199 -
Sensory Optimization of the Hospital Environment
|
N/A | |
Recruiting |
NCT03849248 -
Maternal Scent and Preterm Infant Nutrition
|
N/A | |
Recruiting |
NCT05834907 -
Hands and Hearts Together
|
N/A | |
Not yet recruiting |
NCT05843396 -
Brain Organization, Development, and Response to Intervention in Individual Neonates
|
N/A | |
Completed |
NCT05261503 -
Investigation of the Effectiveness of Environmental Enrichment-Based Intervention in Preterm Infants
|
N/A | |
Completed |
NCT04506541 -
The Effects Of KC On Exclusively Breastfeeding And Baby's Growth And Development According To Attachment Theory
|
N/A | |
Completed |
NCT05778357 -
The Effect of the Covid 19 Pandemic Process on the Neuromotor Developments of 6-24 Month-old Babies
|
||
Active, not recruiting |
NCT05404815 -
Exposure to Plasticisers in the Neonatal Intensive Care Unit
|
||
Completed |
NCT04203589 -
Explorer Babies Early Intervention Program
|
N/A | |
Completed |
NCT03306316 -
Prebiotic in Preterm Infants
|
N/A | |
Completed |
NCT05147480 -
Online Mother-Baby Yoga With Preterm Infants and Their Mothers
|
N/A | |
Recruiting |
NCT04689386 -
Effect of Chest Physiotherapy on the Development of Preterm Infants.
|
N/A | |
Recruiting |
NCT05767242 -
Early Neurophysiological Markers of Language Impairments
|