A New Adaptive Feeding Plan for Newborns | NCT00984230

Studies
A New Adaptive Feeding Plan for Newborns

NCT00984230

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Jun 5, 2013Estimated

Enrollment

186Estimated

Phase

Not Applicable

Conditions

Infant Nutrition

Interventions

BSF
BSF + Lactoferrin + Probiotics
BSF + Lactoferrin + Probiotics + OS

Countries

Austria
France
Greece

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 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Sep 10, 2009

First Submission Date that Met QC Criteria

Sep 24, 2009

First Posted Date

Sep 25, 2009Estimated

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 4, 2013

Last Update Posted Date

Jun 5, 2013Estimated

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 purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

186Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Breastfeeding (Reference)	No Intervention
Basic starter formula: BSF	Active Comparator	Other: BSF
BSF + Lactoferrin + Probiotics + OS	Experimental	Other: BSF + Lactoferrin + Probiotics + OS
BSF + Lactoferrin + Probiotics	Experimental	Other: BSF + Lactoferrin + Probiotics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BSF	Other	feeding amount according to individual baby need	Basic starter formula: BSF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
gut maturation : Specific proteins in stools		3rd day, at 1 week, 2 weeks and 1 month of age

Secondary Outcomes

Measure	Description	Time Frame
Growth and gut microbiota		At 1 month and 2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy newborn infant
Full term infant (≥ 37 weeks gestation; < 42 weeks gestation)
Birth weight from 2500g to 4500g
For the formula-fed groups: babies whose mothers elected not to breastfeed at all
For the breastfed group: babies whose mothers elected to exclusively breastfeed for at least 2 months
Newborn whose parents / caregivers can be expected to comply with the protocol
Study explained and written information given
Informed consent signed

Exclusion Criteria:

Mother who had antibiotics in the 7 days preceding delivery
Caesarian section
Multiple birth
Congenital illness or malformation that may affect normal growth
Significant pre-natal and/or post-natal disease
Newborn participating in another clinical trial

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

3 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Charles Pr Picaud	Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics		Vienna		1090	Austria
Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse

Intervention Browse Module

MeSH Terms

ID	Term
D002066	Busulfan
D007781	Lactoferrin
D019936	Probiotics

Ancestor Terms

ID	Term
D002072	Butylene Glycols
D006018	Glycols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided