Clinical trial NCT00874068: The Effects of Dietary Palmitic Acid Triacylglyceride Position on Bone Strength Parameters in Infants
Official title: The Effects of Dietary Palmitic Acid Triacylglyceride Position on Anthropometric Measures, Bone Strength Parameters, Stool Characteristics and Stool Biochemistry in Preterm and Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Personal Satisfaction
Keywords: term infants
preterm infants
bone strength
Speed of sound (SOS)
Ultrasound
Lead sponsor: Enzymotec
Sponsor class: INDUSTRY
First posted: 2009-04-02
Enrollment: 94
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: bone strength parameters
timeFrame: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
Secondary outcomes:
measure: stool characteristics
timeFrame: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
measure: Antropometric measurements
timeFrame: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Dan Nemet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Litmanovitz I, Bar-Yoseph F, Lifshitz Y, Davidson K, Eliakim A, Regev RH, Nemet D. Reduced crying in term infants fed high beta-palmitate formula: a double-blind randomized clinical trial. BMC Pediatr. 2014 Jun 19;14:152. doi: 10.1186/1471-2431-14-152.