NCT02715895

Brief Summary

Compared with breast milk and another commercially available formula, infants' growth rate after 12 weeks' Friso formula with different ways of processing feeding will be assessed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

June 3, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

March 17, 2016

Last Update Submit

June 1, 2016

Conditions

Body Weight Changes

Keywords

InfantGrowthBody Weight ChangesInfant FormulaRandomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

  • Growth rate of height

    (The height at the end of 12 weeks after feeding minus the height before feeding)/3

    At the end of 12 weeks after feeding

  • Growth rate of weight

    (The weight at the end of 12 weeks after feeding minus the weight before feeding)/3

    At the end of 12 weeks after feeding

  • Growth rate of head circumference

    (The head circumference at the end of 12 weeks after feeding minus the head circumference before feeding)/3

    At the end of 12 weeks after feeding

Secondary Outcomes (15)

  • Growth rate of height

    At the end of 4 weeks after feeding

  • Growth rate of height

    At the end of 8 weeks after feeding

  • Growth rate of weight

    At the end of 4 weeks after feeding

  • Growth rate of weight

    At the end of 8 weeks after feeding

  • Growth rate of head circumference

    At the end of 4 weeks after feeding

  • +10 more secondary outcomes

Study Arms (3)

Friso

EXPERIMENTAL

Friso formula feeding

Dietary Supplement: Friso

Wyeth

EXPERIMENTAL

Wyeth formula feeding

Dietary Supplement: Wyeth

Breast milk

ACTIVE COMPARATOR

Breast milk feeding

Dietary Supplement: Breast milk

Interventions

FrisoDIETARY_SUPPLEMENT

Friso formula feeding on demand for 3 months

Friso
WyethDIETARY_SUPPLEMENT

Wyeth formula feeding on demand for 3 months

Wyeth
Breast milkDIETARY_SUPPLEMENT

Breast milk feeding on demand

Breast milk

Eligibility Criteria

Age4 Weeks - 8 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • to 2 months-old term infants (gestational age ≥37 weeks) checked-up in child care department
  • Gender not limited
  • Though completely understanding the importance of breast milk feeding, subjects' mothers cann't continue to give breast milk feeding owing to their own problems, and have to feed infants with foumula milk only
  • Legal guardians of subjects know the objective of this study and get the tested formula milk for free, then volunteer to participate in the study and sign an informed consent

You may not qualify if:

  • Infants' mothers suffered from infectious diseases during pregnancy
  • Subjects suffered from basic diseases (such as congenital heart disease and genetic metabolic diseases) and congenital deformity
  • Brain damage caused by a variety of factors such as HIE, intraventricular hemorrhage, hypoglycemia
  • Small for gestational age
  • Subjects cann't get full enteral feeding, such as NEC
  • Subjects allergic to cow's milk protein
  • Drop-out Criteria:
  • Subjects in violation of this trial plan (using the other brand formula or not according to the plan)
  • Loss of follow-up
  • Withdrawing the informed consent or asked to quit on their own

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Z1

Zhangzhou, Fujian, 363000, China

Location

Z2

Zhangzhou, Fujian, 363000, China

Location

H2

Haikou, Hainan, 570102, China

Location

H1

Haikou, Hainan, 570206, China

Location

BJ1

Baoji, Shanxi, 721000, China

Location

BJ2

Baoji, Shanxi, 722300, China

Location

MeSH Terms

Conditions

Body Weight Changes

Interventions

Milk, Human

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Chongfan Zhang, Bachelor

    Children's Hospital of Fudan University

    STUDY DIRECTOR

  • Wei Xiang, Master

    Maternal and Child Health Hospital of Hainan Province

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chongfan Zhang, Bachelor

CONTACT

86-21-64931936xt211311@aliyun.com

Ping Zhang, Master

CONTACT

86-21-64931936ttaezo@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2016

First Posted

March 22, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

June 3, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Locations

CN(6)