A Phase 2 interventional study of Infant Formula with prebiotics and Standard Infant Formula in Growth, sponsored by Nutricia Research. Completed at 15 sites in 6 countries. Open to participants aged Up to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-14.
Sponsored by Nutricia Research (part of Danone) · Phase 2, Interventional, and Prevention
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.
Nutricia Research is the lead sponsor of 51 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Infants of pregnant women/mothers:
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:
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:
Partially hydrolysed whey protein based infant formula containing prebiotics.
Other: Infant Formula with prebiotics
Intact cow's milk protein based infant formula containing prebiotics.
Other: Standard Infant Formula
Intervention group: Partially hydrolysed whey protein based infant formula containing prebiotics.
Control group: Intact cow's milk protein based infant formula containing prebiotics
Weight gain
Weight gain in grams per day from baseline until 17 weeks of age
Time frame: 17 weeks
Length
Gain in Recumbent length (mm/day)
Time frame: 17 weeks
Head circumference
Gain in Head circumference (mm/day)
Time frame: 17 weeks
Mid-upper arm circumference
Gain in Mid-upper arm circumference (mm/day)
Time frame: 17 weeks
Anthropometric measures
Z scores of anthropometric parameters
Time frame: 17 weeks
Albumin level
Albumin in blood (g/L)
Time frame: 17 weeks
Calcium level
Calcium in blood (mmol/l)
Time frame: 17 weeks
Phosphorus level
Phosphorus in blood (mmol/l)
Time frame: 17 weeks
Iron level
Iron (µmol/l) in blood
Time frame: 17 weeks
Magnesium level
Magnesium (mmol/l) in blood
Time frame: 17 weeks
Nitrogen level
Blood urea nitrogen (mmol/l)
Time frame: 17 weeks
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
Time frame: 17 weeks
Number of adverse events
Number of adverse events (by "System/Organ Class" and "Preferred term" according the MedDRA)
Time frame: 17 weeks
Concomitant medications
All concomitant medications (according to WHO-DDE) will be summarised in individual data listing
Time frame: 17 weeks
Regurgitation
Regurgitation nr of occurrences per week
Time frame: 4, 8, 13 and 17 weeks
Vomiting
Vomiting nr of occurrences per week
Time frame: 4, 8, 13 and 17 weeks
Diarrhoea
Number of infants with diarrhoea (definition adapted from WHO definition based on number of watery stools per day)
Time frame: 4, 8, 13 and 17 weeks
Constipation
Number of infants with constipation (definition adapted from Rome II criteria based on number of defecations and consistency per week)
Time frame: 4, 8, 13 and 17 weeks
Plan to share: No
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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