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

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ClinicalTrials.gov Identifier: NCT03055052
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infant, Premature, Nutrition Other: Standard formula for preterm infants Other: Formula with higher protein and new fat blend for preterm infants Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants
Study Start Date : January 2017
Actual Primary Completion Date : March 18, 2018
Actual Study Completion Date : June 25, 2018

Arm Intervention/treatment
Active Comparator: Control Formula
Standard formula for preterm infants.
Other: Standard formula for preterm infants
Reconstituted in water and given to infants at more than 50% of feedings.

Experimental: Experimental formula
Formula with higher protein and new fat blend for preterm infants.
Other: Formula with higher protein and new fat blend for preterm infants
Reconstituted in water and given to infants at more than 50% of feedings.




Primary Outcome Measures :
  1. Growth in terms of weight gain per day [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Growth in terms of length and head circumference [ Time Frame: Till infant reaches 3kg (study completion), expected within 3 months ]
  2. Feeding tolerance (frequency of regurgitation, stool frequency and consistency) [ Time Frame: Till infant reaches 3kg (study completion), expected within 3 months ]
  3. Incidence of adverse events [ Time Frame: 30 days post infant stopping study infant formula intake upon reaching 3kg ]


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Ages Eligible for Study:   up to 33 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055052


Locations
Vietnam
Tu Du Hospital
Ho Chi Minh City, Ho Chi Minh, Vietnam
Sponsors and Collaborators
Nestlé
Investigators
Study Chair: Leslie Tan Nestlé

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03055052     History of Changes
Other Study ID Numbers: 14.25.INF
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No