Personal Satisfaction
Conditions
Keywords
term infants, preterm infants, bone strength, Speed of sound (SOS), Ultrasound
Brief summary
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on bone strength parameters.
Detailed description
InFatTM is an advanced basic-fat ingredient, which mimics the fat composition and properties of human milk fat and enabling optimal intake of the essential calcium and energy (in the form of fatty acids) and easy digestion. These benefits are the results of a unique fatty acid composition on the glycerol backbone, which ensure high level of palmitic acid at the middle (sn-2) position. The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on bone strength parameters, anthropometric parameters, wellbeing and stool characteristics in term and preterm infants.
Interventions
high sn-2 palmitic acid oil based infant formula
standard vegetable oil based infant formula
Sponsors
Enzymotec
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
Yes
Inclusion criteria
1. Gestational age above 32 weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination. 2. Birth weight appropriate for gestational age (AGA) using current CDC growth charts, and above 1750gr. 3. The mother had unequivocally decided not to breast-feed (in formula groups) or the mother had decided to breast feed (in human breast milk group). 4. The infant is apparently healthy. 5. Parental/ legal guardian written inform consent 6. Apgar after 5 minutes \>7 7. Enrolled within their first 14 days of life for term infants and first month of life for preterm infants 8. At enrollment: clinical stability and acceptable weight gain
Exclusion criteria
1. The infant suffer from a congenital or chromosomal disorder (Cystic fibrosis, Tracheomalacia, Tracheoesophageal fistula, major congenital heart disease, down-syndrome) 2. The infant suffer from neonatal morbidities: * Bronchopulmonary dysplasia (BPD) * Intraventricular Hemorrhage3-4 (IVH) * Necrotizing Enterocolitis (NEC) 3. Laboratory or clinical sings of Osteopenia 4. The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula) 5. The mother suffers from any disease or disability that may interfere with her ability to take care of her infant 6. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bone strength parameters | baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| stool characteristics | baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks |
| Antropometric measurements | baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks |
Countries
Israel
Outcome results
None listed