A New Adaptive Feeding Plan for Newborns

• Sponsor: Nestlé (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00984230
• Collaborator: (none)
• Enrollment: 186
• Locations: 6
• Arms: 4
• Duration (Months): 17
• Patients Per Site: 31
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infant Nutrition	Other: BSF; Other: BSF + Lactoferrin + Probiotics; Other: BSF + Lactoferrin + Probiotics + OS	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 186 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Official Title: A New Adaptive Feeding Plan for Newborns: Effects on Gut Maturity and Gut Microbiota
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Breastfeeding (Reference)
Active Comparator: Basic starter formula: BSF	Other: BSF; feeding amount according to individual baby need
Experimental: BSF + Lactoferrin + Probiotics + OS	Other: BSF + Lactoferrin + Probiotics + OS; feeding amount according to individual baby need
Experimental: BSF + Lactoferrin + Probiotics	Other: BSF + Lactoferrin + Probiotics; feeding amount according to individual baby need

Outcome Measures

Primary Outcome Measures

1. gut maturation : Specific proteins in stools [3rd day, at 1 week, 2 weeks and 1 month of age]

Secondary Outcome Measures

1. Growth and gut microbiota [At 1 month and 2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 3 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pediatrics	Vienna		Austria	1090
2	Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse	Lyon CEDEX 04		France	69317
3	Maternité Régionale, Service de Néonatologie	Nancy		France	54042
4	Service de Néonatologie	Nantes		France	44093
5	Hôpital Charles Nicolle, Département de Pédiatrie	Rouen		France	76031
6	Alexandra Regional General Hospital, Department of Neonatology	Palaio Faliro	Athens	Greece	17562

Sponsors and Collaborators

• Nestlé

Investigators

• Principal Investigator: Jean-Charles Pr Picaud, Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT00984230
• Other Study ID Numbers: 07.22.INF
• First Posted: Sep 25, 2009
• Last Update Posted: Jun 5, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Nestlé: Infant Formula; Gut
• Additional relevant MeSH terms: Lactoferrin

Study Results

No Results Posted as of Jun 5, 2013