Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants

Study Overview
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Brief Summary
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This study evaluates the effects of infant formula with higher protein level and improved fat blend on growth and feeding tolerance in preterm infants. Half of the subjects will receive a standard infant formula, while the other half will receive a infant formula with a higher protein level and improved fat blend.

Detailed Description
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When an infant is born prematurely, the supply of nutrients supporting normal growth and development is interrupted. There is less time to accrue adequate nutrient stores and foetal tissue. The nutritional goal for the preterm infant is to have satisfactory functional development and catch up on growth to match the rate of a full term infant. To achieve this, it is recommended for the infant to have adequate protein intake and suitable fat blend.

Official Title
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Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants

Conditions
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Infant, Premature, Nutrition

Intervention / Treatment
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* Other: Standard formula for preterm infants
* Other: Formula with higher protein and new fat blend for preterm infants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Less than or equal to 33 weeks 0 days Birth weight less than or equal to 2000g. Infant is anticipated to receive the study formula for ≥ 3 consecutive weeks At entry into Full Enteral Feeding, study formula will be provided at 50% or more of total enteral feedings. Written informed consent has been obtained from the parent/legally authorized representative (LAR). Exclusion Criteria: Peri-/intra-ventricular hemorrhage Renal disease Hepatic dysfunction Major congenital malformations Suspected or documented systemic or congenital infections Cardiac, respiratory, endocrinologic, hematologic, GI, or other systemic diseases that may impact growth Suspected or documented maternal substance abuse Infants who have received any experimental treatment or intervention

Ages Eligible for Study
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Maximum Age: 33 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Formula<br>Standard formula for preterm infants. | Other: Standard formula for preterm infants<br>* Reconstituted in water and given to infants at more than 50% of feedings.<br>|
| Experimental: Experimental formula<br>Formula with higher protein and new fat blend for preterm infants. | Other: Formula with higher protein and new fat blend for preterm infants<br>* Reconstituted in water and given to infants at more than 50% of feedings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth in terms of weight gain per day |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth in terms of length and head circumference |  | Till infant reaches 3kg (study completion), expected within 3 months | 
| Feeding tolerance (frequency of regurgitation, stool frequency and consistency) |  | Till infant reaches 3kg (study completion), expected within 3 months | 
| Incidence of adverse events |  | 30 days post infant stopping study infant formula intake upon reaching 3kg |