Human Milk Fortifier - Growth Evaluation

Premature Birth Clinical Trial

Official title:

Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771588
• Other study ID #: 08.08.INF
• Status: Completed
• Phase: N/A
• First received: January 8, 2013
• Last updated: May 4, 2016
• Start date: April 2011
• Est. completion date: March 2015

Study information

• Verified date: May 2016
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• Birth weight =1500 g AND/OR gestational age =32 weeks (determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof)

• Male or female

• Tolerating an enteral intake of human milk, donor milk or a combination at =100 mL/kg/d for = 24 h

• Subject is anticipated to receive human milk, donor milk or a combination for = 3 consecutive weeks after having achieved full fortification with volume intake contained between 150 and 180 mL/kg/d.

• Written informed consent has been obtained from the legal representative(s).

Exclusion Criteria:

• Infants with current systemic disease

• Infants with a history of systemic disease

• Any congenital anomalies of the GI tract that significantly interfere with nutrition and growth or previous GI surgery.

• Small size for gestational age (SGA) - body weight ? 5th percentile for that gestational age.

• Infants diagnosed with any inherent metabolic disease.

• Infants diagnosed with any chromosomic disease.

• Receiving any commercial formula supplementation to breast milk.

• Receiving steroids at the time of enrollment.

• Participation in another nutritional clinical trial that may affect outcomes of this study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Premature Birth

Intervention

Dietary Supplement:
• Human milk fortifier

Locations

Country	Name	City	State
Belgium	CHR de la Citadelle	Liège
France	Hôpital des Enfants - CHU Pellegrin	Bordeaux
France	CHU Caen	Caen
France	CHU Grenoble	Grenoble
France	Hôpital de la Croix-Rousse	Lyon
France	Hôpital de la Conception Marseille	Marseille
France	Maternité Régionale	Nancy
France	Hôpital Clocheville Tours	Tours
Germany	Klinikum Ernest von Bergmann	Potsdam
Italy	Policlinico Mangiagalli e Regina Elena	Milano
Switzerland	Kinderspital	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day.		21 days	No