Clinical trial NCT03062761: A Clinical Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Growth
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 380
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Weight gain
timeFrame: 17 weeks
Secondary outcomes:
measure: Length
timeFrame: 17 weeks
measure: Head circumference
timeFrame: 17 weeks
measure: Mid-upper arm circumference
timeFrame: 17 weeks
measure: Anthropometric measures
timeFrame: 17 weeks
measure: Albumin level
timeFrame: 17 weeks
measure: Calcium level
timeFrame: 17 weeks
measure: Phosphorus level
timeFrame: 17 weeks
measure: Iron level
timeFrame: 17 weeks
measure: Magnesium level
timeFrame: 17 weeks
measure: Nitrogen level
timeFrame: 17 weeks
measure: Number of subjects with adverse events
timeFrame: 17 weeks
measure: Number of adverse events
timeFrame: 17 weeks
measure: Concomitant medications
timeFrame: 17 weeks
measure: Regurgitation
timeFrame: 4, 8, 13 and 17 weeks
measure: Vomiting
timeFrame: 4, 8, 13 and 17 weeks
measure: Diarrhoea
timeFrame: 4, 8, 13 and 17 weeks
measure: Constipation
timeFrame: 4, 8, 13 and 17 weeks
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University of Turku Children's Allergy and Asthma Clinic
city: Lille
country: France
facility: Groupement des Hopitaux de l'institut Catholique de Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Berlin
country: Germany
facility: Vivantes Klinik für Geburtsmedizin, Klinikum Neukölln
city: Bramsche
country: Germany
facility: Paediatric Practice
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
city: Białystok
country: Poland
facility: Poliklinika Ginekologiczno-Poloznicza Sp. z o.o. Sp.k
city: Kraków
country: Poland
facility: Specjalistyczna Poradnia Medyczna Przylądek Zdrowia
city: Poznań
country: Poland
facility: POLMED / Instytut Mikroekologii
city: Rzeszów
country: Poland
facility: Korczowski Bartosz, Gabinet Lekarski
city: Siemianowice Śląskie
country: Poland
facility: NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska
city: Barcelona
country: Spain
facility: Hospital Quirónsalud Barcelona
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus (IISPV)
city: Tarragona
country: Spain
facility: Hospital Universitari de Tarragona Joan XXIII
Study officials:
References: