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Clinical Trial of Infant Formula-fed

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715895
Recruitment Status : Unknown
Verified March 2016 by Maternal and Child Health Care Hospital of Hainan Province.
Recruitment status was:  Not yet recruiting
First Posted : March 22, 2016
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Maternal and Child Health Care Hospital of Hainan Province

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.

Condition or disease Intervention/treatment Phase
Body Weight Changes Dietary Supplement: Friso Dietary Supplement: Wyeth Dietary Supplement: Breast milk Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Clinical Trial of Infant Formula-fed
Study Start Date : April 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Friso
Friso formula feeding
Dietary Supplement: Friso
Friso formula feeding on demand for 3 months

Experimental: Wyeth
Wyeth formula feeding
Dietary Supplement: Wyeth
Wyeth formula feeding on demand for 3 months

Active Comparator: Breast milk
Breast milk feeding
Dietary Supplement: Breast milk
Breast milk feeding on demand




Primary Outcome Measures :
  1. Growth rate of height [ Time Frame: At the end of 12 weeks after feeding ]
    (The height at the end of 12 weeks after feeding minus the height before feeding)/3

  2. Growth rate of weight [ Time Frame: At the end of 12 weeks after feeding ]
    (The weight at the end of 12 weeks after feeding minus the weight before feeding)/3

  3. Growth rate of head circumference [ Time Frame: At the end of 12 weeks after feeding ]
    (The head circumference at the end of 12 weeks after feeding minus the head circumference before feeding)/3


Secondary Outcome Measures :
  1. Growth rate of height [ Time Frame: At the end of 4 weeks after feeding ]
    (The height at the end of 12 weeks after feeding minus the height before feeding)/1

  2. Growth rate of height [ Time Frame: At the end of 8 weeks after feeding ]
    (The height at the end of 12 weeks after feeding minus the height before feeding)/2

  3. Growth rate of weight [ Time Frame: At the end of 4 weeks after feeding ]
    (The weight at the end of 12 weeks after feeding minus the weight before feeding)/1

  4. Growth rate of weight [ Time Frame: At the end of 8 weeks after feeding ]
    (The weight at the end of 12 weeks after feeding minus the weight before feeding)/2

  5. Growth rate of head circumference [ Time Frame: At the end of 4 weeks after feeding ]
    (The head circumference at the end of 12 weeks after feeding minus the head circumference before feeding)/1

  6. Growth rate of head circumference [ Time Frame: At the end of 8 weeks after feeding ]
    (The head circumference at the end of 12 weeks after feeding minus the head circumference before feeding)/2

  7. Defecate frequency [ Time Frame: At the end of 4 weeks after feeding ]
    Evaluated by subjects' guardians

  8. Defecate frequency [ Time Frame: At the end of 8 weeks after feeding ]
    Evaluated by subjects' guardians

  9. Defecate frequency [ Time Frame: At the end of 12 weeks after feeding ]
    Evaluated by subjects' guardians

  10. Fresh stool character [ Time Frame: At the end of 4 weeks after feeding ]
    Fresh stool (collect stool data over 3 days) character at the end of 4 weeks, evaluated by Bristol stool shape chart and divided into 7 type, the subjects' guardians need to record it and call to child care doctor

  11. Fresh stool character [ Time Frame: At the end of 8 weeks after feeding ]
    Fresh stool (collect stool data over 3 days) character at the end of 8 weeks, evaluated by Bristol stool shape chart and divided into 7 type, the subjects' guardians need to record it and call to child care doctor

  12. Fresh stool character [ Time Frame: At the end of 12 weeks after feeding ]
    Fresh stool (collect stool data over 3 days) character at the end of 12 weeks, evaluated by Bristol stool shape chart and divided into 7 type, the subjects' guardians need to record it and call to child care doctor

  13. Eye secretions [ Time Frame: After waking up at the end of 4 weeks after feeding ]
    The subjects' guardian needs to take photos of eye secretions and send photos to research Centre, evaluated by specialists

  14. Eye secretions [ Time Frame: After waking up at the end of 8 weeks after feeding ]
    The subjects' guardian needs to take photos of eye secretions and send photos to research Centre, evaluated by specialists

  15. Eye secretions [ Time Frame: After waking up at the end of 12 weeks after feeding ]
    The subjects' guardian needs to take photos of eye secretions and send photos to research Centre, evaluated by specialists



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1 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

Exclusion Criteria:

  • 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
  • Subjects used antibiotics before inclusion
  • Subjects participate in other clinical trials before inclusion or during this trial

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

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): NCT02715895


Contacts
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Contact: Chongfan Zhang, Bachelor 86-21-64931936 xt211311@aliyun.com
Contact: Ping Zhang, Master 86-21-64931936 ttaezo@163.com

Locations
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China, Fujian
Z1
Zhangzhou, Fujian, China, 363000
Contact: Chunchou Luo, Bachelor    13615060339    wyj943@yeah.net   
Contact: Xiuyu Chen, Bachelor    18960017707    923386271@qq.com   
Z2
Zhangzhou, Fujian, China, 363000
Contact: Chunchou Luo, Bachelor    13615060339    wyj943@yeah.net   
Contact: Liying Gao    13695938067    978577921@qq.com   
China, Hainan
H2
Haikou, Hainan, China, 570102
Contact: Wei Xiang, Master    18608981299    13907533529@163.com   
Contact: Yanping Jia, Bachelor    13976608556    Jiayanping1962@163.com   
H1
Haikou, Hainan, China, 570206
Contact: Wei Xiang, Master    18608981299    13907533529@163.com   
Contact: Ling Yang, Bachelor    18689856312    yling.com@163.com   
China, Shanxi
BJ1
Baoji, Shanxi, China, 721000
Contact: Qin Li, Bachelor    18991738023    liqinn2001@163.com   
Contact: Ying Cao, Bachelor    18991736675      
BJ2
Baoji, Shanxi, China, 722300
Contact: Qin Li, Bachelor    18991738023    liqinn2001@163.com   
Contact: Yongqiang Zeng    18591728186      
Sponsors and Collaborators
Maternal and Child Health Care Hospital of Hainan Province
Investigators
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Study Director: Chongfan Zhang, Bachelor Children's Hospital of Fudan University
Principal Investigator: Wei Xiang, Master Maternal and Child Health Hospital of Hainan Province
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Responsible Party: Maternal and Child Health Care Hospital of Hainan Province
ClinicalTrials.gov Identifier: NCT02715895    
Other Study ID Numbers: CJEBP-01
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Maternal and Child Health Care Hospital of Hainan Province:
Infant
Growth
Body Weight Changes
Infant Formula
Randomized Controlled Trial
Additional relevant MeSH terms:
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Body Weight
Body Weight Changes