Infant Sleep Behaviour and Gut Microbacteria | NCT02836119

Studies
Infant Sleep Behaviour and Gut Microbacteria

NCT02836119

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Jun 12, 2018Actual

Enrollment

128Estimated

Phase

Not provided

Conditions

Gut Microbiota and Sleep in Infants

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jul 11, 2016

First Submission Date that Met QC Criteria

Jul 13, 2016

First Posted Date

Jul 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2018

Last Update Posted Date

Jun 12, 2018Actual

Name	Class
University Children's Hospital, Zurich	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The overarching study aim is to evaluate the development of sleep behavior and gut microbiota (GMB), and their potential interaction, during the vulnerable period of the first year of life. Age-specific fecal profiles with bacterial genome sequencing will provide new insight into the functional coevolution of the GMB and host sleep behavior.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Not provided

Description

Enrollment

128Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Differences in sleep phenotypes (high fragmentation vs low fragmentation, short vs long sleepers)		across the first twelve months of life
Differences in Gut Microbiome Diversity (alpha, beta, Shannon) and taxa abundance and association with sleep phenotypes		across the first twelve months of life

Secondary Outcomes

Measure	Description	Time Frame
Association of primary outcome measures with cognitive and behavioral questionnaires (Food, development, Sleep)		across the first twelve months of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Good general health status
exclusively breastfed (at baseline)
vaginal birth delivery mode

Exclusion Criteria:

C-section delivery mode
Formula fed (at baseline)
Diseases or lesions of the central nervous system, acute pediatric disease, developmental/neurologic/metabolic disorders, chronic medical conditions, or head injury
Family history of narcolepsy/psychosis/bipolar disorder
Conceptual age of < 37 or > 42 weeks
Low birth weight (< 2500g)
Co-sleeping during > 50% of the time in the same bed
Medication use affecting sleep/alertness
Vaccination (2 weeks prior to study)
Antibiotics (3 months prior to study)
Travelling across a time zone (within 1 month prior to study)
intrauterine drug exposure, intrauterine infection, known or suspected drug or alcohol abuse
Insufficient knowledge of German (parents)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

13 Months

Standard Ages

Child

Study Population

Healthy infants

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarah F. Schoch, M.Sc.	Contact	044 255 93 68		babysleep@usz.ch

Overall Officials

Name	Affiliation	Role
Salome Kurth, Dr. sc. nat.	Clinic for Pulmonology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich	Recruiting	Zurich		8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided