NCT03055052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

January 26, 2017

Last Update Submit

August 2, 2018

Conditions

Infant, Premature, Nutrition

Outcome Measures

Primary Outcomes (1)

  • Growth in terms of weight gain per day

    21 days

Secondary Outcomes (3)

  • 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

Study Arms (2)

Control Formula

ACTIVE COMPARATOR

Standard formula for preterm infants.

Other: Standard formula for preterm infants

Experimental formula

EXPERIMENTAL

Formula with higher protein and new fat blend for preterm infants.

Other: Formula with higher protein and new fat blend for preterm infants

Interventions

Standard formula for preterm infantsOTHER

Reconstituted in water and given to infants at more than 50% of feedings.

Control Formula
Formula with higher protein and new fat blend for preterm infantsOTHER

Reconstituted in water and given to infants at more than 50% of feedings.

Experimental formula

Eligibility Criteria

AgeUp to 33 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tu Du Hospital

Ho Chi Minh City, Ho Chi Minh, Vietnam

Location

Related Publications (1)

  • Thanh LQ, Chen Y, Hartweg M, Thi Nguyen TA. Effects of higher protein formula with improved fat blend on growth, feeding tolerance and nutritional biomarkers in preterm infants: A double-blind, randomized, controlled clinical trial. Pediatr Neonatol. 2022 May;63(3):227-238. doi: 10.1016/j.pedneo.2021.09.007. Epub 2021 Dec 4.

    PMID: 35000893DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Food, Formulated

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Foods, SpecializedFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Leslie Tan

    Société des Produits Nestlé (SPN)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2017

First Posted

February 16, 2017

Study Start

January 1, 2017

Primary Completion

March 18, 2018

Study Completion

June 25, 2018

Last Updated

August 3, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)