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

August 2, 2018 updated by: Nestlé
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Ho Chi Minh
      • Ho Chi Minh City, Ho Chi Minh, Vietnam
        • Tu Du Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Growth in terms of weight gain per day
Time Frame: 21 days
21 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Study Chair: Leslie Tan, Nestlé

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

March 18, 2018

Study Completion (Actual)

June 25, 2018

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

February 15, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 14.25.INF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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