A Clinical Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants

Growth Clinical Trial

— TENUTO  

Official title:

A Randomized, Controlled, Double Blind, Parallel Group, Multi-country Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062761
• Other study ID #: EBB15BL89832
• Status: Completed
• Phase: Phase 2
• Start date: April 27, 2017
• Est. completion date: November 12, 2018

Study information

• Verified date: January 2019
• Source: Nutricia Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is universally accepted that the best nutrition for a new-born infant is breast milk. Breast milk provides a complete set of nutrients to support growth and development of children in early life, including components that have a beneficial effect on gut health and the body's ability to defend itself against infectious organisms and other invaders (immune system).However, it may occur that a mother is unable to breastfeed her child, or chooses not to breastfeed. In such cases, an infant formula inspired by breast milk is the best alternative. Research is done to optimize milk formula for infants. One of these formulas contains 'partially hydrolyzed' proteins instead of intact proteins, meaning the proteins in this formula are broken down into smaller pieces. These smaller pieces of protein make the milk more suitable for consumption by infants at risk of developing cow's milk allergy. These types of partially hydrolyzed protein formulas have been on the market for several years, in particular for children with a family risk of allergy. So far, no safety related issues have been reported. It is also known that weight gain of infants receiving partially hydrolyzed proteins in general is appropriate according to the World Health Organisation growth standards.

The main purpose of the TENUTO study is to demonstrate that infants who receive a specific partially hydrolyzed protein infant formula for the first 4 months of life have a similar weight gain compared to infants receiving standard infant formula with intact proteins. A group of infants who receive breast milk only is also included for comparison.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: November 12, 2018
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

1. Healthy term infants (gestational age = 37 weeks + 0 days and = 41 weeks + 6 days);

2. Infants' age at enrolment = 14 days;

3. Birth weight within normal range for gestational age and sex (10th to 90th percentile according to the WHO Child Growth Standards - or local growth standards if available);

4. Head circumference at inclusion within normal range for age and sex (within 2 SD curves according to WHO Child Growth Standards - or local growth standards if available);

5. Infant formula arms: infants who are exclusively formula fed by time of randomisation with a maximum infants' age of 14 days (infants of mothers who choose not to breastfeed or mothers who cease breastfeeding for any reason before the infant is 14 days of age); OR Breastfeeding reference arm: infants who are exclusively breastfed and whose mothers are intending to exclusively breastfeed their infant at least until the infant is 17 weeks of age; 6 Written informed consent from parent(s) and/or legal guardian(s) aged = 18 years.

Exclusion Criteria:

Infants of pregnant women/mothers:

1. who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;

2. known to have a significant medical condition (including during pregnancy) that might interfere with the study or known to affect intra-uterine growth (e.g. placenta previa, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oral medication), as per investigator's clinical judgement;

Infants of parents:

3. who are incapable to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements;

Infants:

4. who have to be fed with a special diet other than standard (non-hydrolysed) cow's milk based infant formula

5. known to have current or previous illnesses/conditions which could interfere with the study or its outcome parameters, such as gastrointestinal malformations, congenital metabolic disorders, immune deficiency or major surgery, as per investigator's clinical judgement;

6. with any history of, or current participation in any other study involving investigational or marketed products.

Related Conditions & MeSH terms

• Growth

Intervention

Other:
• Infant Formula with prebiotics
Intervention group: Partially hydrolysed whey protein based infant formula containing prebiotics.
• Standard Infant Formula
Control group: Intact cow's milk protein based infant formula containing prebiotics

Locations

Country	Name	City	State
Finland	University of Turku Children's Allergy and Asthma Clinic	Turku
France	Groupement des Hopitaux de l'institut Catholique de Lille	Lille
France	Hospices Civils de Lyon	Lyon
Germany	Vivantes Klinik für Geburtsmedizin, Klinikum Neukölln	Berlin
Germany	Paediatric Practice	Bramsche
Netherlands	Gelre Ziekenhuizen	Apeldoorn
Poland	Poliklinika Ginekologiczno-Poloznicza Sp. z o.o. Sp.k	Bialystok
Poland	Specjalistyczna Poradnia Medyczna Przyladek Zdrowia	Kraków
Poland	POLMED / Instytut Mikroekologii	Poznan
Poland	Korczowski Bartosz, Gabinet Lekarski	Rzeszów
Poland	NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska	Siemianowice Slaskie
Spain	Hospital Quirónsalud Barcelona	Barcelona
Spain	Hospital General Universitario de Elche	Elche
Spain	Hospital Universitari Sant Joan de Reus (IISPV)	Reus
Spain	Hospital Universitari de Tarragona Joan XXIII	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Countries where clinical trial is conducted

Finland,  France,  Germany,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain	Weight gain in grams per day from baseline until 17 weeks of age	17 weeks
Secondary	Length	Gain in Recumbent length (mm/day)	17 weeks
Secondary	Head circumference	Gain in Head circumference (mm/day)	17 weeks
Secondary	Mid-upper arm circumference	Gain in Mid-upper arm circumference (mm/day)	17 weeks
Secondary	Anthropometric measures	Z scores of anthropometric parameters	17 weeks
Secondary	Albumin level	Albumin in blood (g/L)	17 weeks
Secondary	Calcium level	Calcium in blood (mmol/l)	17 weeks
Secondary	Phosphorus level	Phosphorus in blood (mmol/l)	17 weeks
Secondary	Iron level	Iron (µmol/l) in blood	17 weeks
Secondary	Magnesium level	Magnesium (mmol/l) in blood	17 weeks
Secondary	Nitrogen level	Blood urea nitrogen (mmol/l)	17 weeks
Secondary	Number of subjects with adverse events	Adverse events (by "System/Organ Class" and "Preferred term" according the MedDRA ) will be reported as number of subjects with at least one adverse event	17 weeks
Secondary	Number of adverse events	Number of adverse events (by "System/Organ Class" and "Preferred term" according the MedDRA)	17 weeks
Secondary	Concomitant medications	All concomitant medications (according to WHO-DDE) will be summarised in individual data listing	17 weeks
Secondary	Regurgitation	Regurgitation nr of occurrences per week	4, 8, 13 and 17 weeks
Secondary	Vomiting	Vomiting nr of occurrences per week	4, 8, 13 and 17 weeks
Secondary	Diarrhoea	Number of infants with diarrhoea (definition adapted from WHO definition based on number of watery stools per day)	4, 8, 13 and 17 weeks
Secondary	Constipation	Number of infants with constipation (definition adapted from Rome II criteria based on number of defecations and consistency per week)	4, 8, 13 and 17 weeks