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the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children (EHCONSGDMC)

Primary Purpose

Malnutrition, Child, Malnourishment, Nutritional Deficiency

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
high caloric oral nutritional supplements
nutritional education
dietary guidance
Sponsored by
Children's Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition, Child focused on measuring Oral Nutritional Supplements, Physique Growth, Neuropsychological Development

Eligibility Criteria

1 Year - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 1-3 years BMI for Age Z-score<-2 Height-for-age z score<-2 Total daily energy intake<75% of recommended nutrient intake The child's guardian is willing to participate in this study and sign an informed consent form. Exclusion Criteria: Chronic or severe infectious disease (e.g., chronic hepatitis, HIV or tuberculosis infection) Certain congenital or genetic diseases affecting physical growth and development (congenital heart disease, Down's syndrome, infantile anorexia nervosa, etc.), malignancies and use of drugs (diuretics, appetite stimulants, steroids and growth hormones, etc.) Severe gastrointestinal disorders (e.g., celiac disease, short bowel syndrome, inflammatory bowel disease, etc.) Acute and chronic respiratory/digestive tract infections within 2 weeks prior to enrollment Allergy or contraindication to any of the ingredients in the high-energy total nutrition formula used in this study Have used high-energy enteral nutrition preparations for the last 3 months

Sites / Locations

  • Anhui Provincial Children's Hospital
  • Children's Hospital of The Capital Institute of Pediatrics
  • Growth, Development and Mental health of Children and Adolescence Center
  • Guangzhou Women and Children's Medical Center
  • Guiyang Maternity and Child Health Care Hospital
  • Hunan Children's Hospital
  • Nanjing Maternity and Child Health Care Hospital
  • Jiangxi Maternal and Child Health Hospital
  • Baoji Maternity and Child Healthcare Hospital
  • Xianyang Children's Hospital
  • Chengdu Women's and Children's Central Hospital,School of Medicine,University of Electronic Science and Technology of China
  • Kunming Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high caloric oral nutritional supplements group

nutritional education and dietary guidance group

Arm Description

Participants aged 1 to 3 years who are malnourished (underweight and wasting). They will receive nutritional education,dietary instruction and daily high caloric oral nutritional supplements for 12 months.

Participants aged 1 to 3 years who are malnourished (underweight and wasting). They will receive nutrition education and dietary instruction.

Outcomes

Primary Outcome Measures

BMI for Age Z-score(BAZ)
Trained research assistants or health care practitioners obtain weight in kilograms and height in centimeters (mean of 3 consecutive measurements). Height and weight will be combined to report BMI in kg/m^2.Then, the BAZ is calculated using WHO2011v3.2.2 software.

Secondary Outcome Measures

Dietary Diary
Participants provide a dietary diary over an average two-day period through a WeChat app each visit. The app prompts participants to record and estimate details of all meals and snacks they consumed, especially formula used in the study.
BMI for Age Z-score(BAZ)
Trained research assistants or health care practitioners obtain weight in kilograms and height in centimeters (mean of 3 consecutive measurements). Height and weight will be combined to report BMI in kg/m^2.Then, the BAZ is calculated using WHO2011v3.2.2 software.
Weight for Age Z-score(WAZ)
Trained research assistants or health care practitioners obtain weight in kilograms using a standardized approach. Weight is measured using a precision digital scale or mechanical scale(mean of 3 consecutive measurements). Then, the WAZ is calculated using WHO2011v3.2.2 software.
Height for Age Z-score(HAZ)
Trained research assistants or health care practitioners obtain height in centimeters using a standardized approach. Height is measured with a calibrated stadiometer(mean of 3 consecutive measurements). Then, the HAZ is calculated using WHO2011v3.2.2 software.
Gesell Developmental Scale Test
Mainly assesses participants in 5 areas:adaptive behavior, gross motor, fine motor, language behavior,personal-social behavior, the evaluation finally calculates the developmental quotient (DQ) of each area. Diagnostic criteria: DQ is more than or equal to 86 is normal, DQ is marginal between 76 and 85, DQ is mild mental retardation between 55 and 75, DQ is moderate mental retardation between 40 and 54, DQ is severe mental retardation between 25 and 39, and DQ is less than or equal to 25 is extremely severe mental retardation.
Infants - Junior High School Students Social Competence Test (S-M test)
The scale, derived from the revised version of the Japanese Social Competence test (S-M test) and revised by a Chinese researcher, is applicable to children from 6 months of age to 14 years of age and includes 132 items in 6 sections with 7 starting ages, which are filled in item by item by parents or daily caregivers according to the appropriate age, with ≥10 being normal.
Pediatric Quality of Life Inventory (PedsQL)
The quality of life of the participants is assessed using the Pediatric Quality of Life Inventory.The Infant Scale or Generic Core Scales is completed according to age.Scores are transformed on a scale from 0 to 100,with higher scores indicating better quality of life.
the Chinese version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
The quality of life of parents is assessed using the WHOQOL-BREF.The WHOQOL-BREF, comprises 26 items, two general items and 24 others, across the following four domains: physical (7 items), psychological (6 items), social (3 items), and environmental (8 items).Calculate the average score of all items in each domain, converted into a score of 4 to 20 or 0 to100 by two algorithms,with higher scores indicating better quality of life.
Gut Health Questionnaire
A questionnaire is used to understand gut health, including entries on the Bristol Stool Scale (to assess stool status), the average number of bowel movements per day, and the frequency of bloating and abdominal pain.
Infectious Diseases Related Questionnaire
A infectious disease-related questionnaire is used to understand immune function, including the number and duration of upper respiratory tract infections, infectious diarrhea.
Blood Routine Test
Blood routine test is completed at 0, 6 and 12 months of enrollment for safety analysis.Includes the following parameters:white blood cell count,red blood cell count,hemoglobin,mean corpuscular hemoglobin concentration,platelet,standard deviation in red cell distribution width,coefficient variation of red blood cell volume distribution width,platelet distribution width,mean platelet volume,platelet larger cell ratio,thrombocytocrit,neutrophil ratio,lymphocyte ratio,monocyte ratio,eosinophil ratio,basophil ratio,neutrophil count,lymphocyte count,monocyte count,eosinophil count,basophil count.
Liver Function Test
Liver function test is completed at 0, 6 and 12 months of enrollment for safety analysis.Includes the following parameters:total protein,albumin,globulin,alanineamino transferase,aspartate amino transferase,bilirubin,direct bilirubin,total bile acid,alkaline phosphatase,amma-glutamyl transpeptidase.
Renal Function Test
Renal function test is completed at 0, 6 and 12 months of enrollment for safety analysis.Includes the following parameters:creatinine,blood urea nitrogen.
Urine Routine Test
Urine routine test is completed at 0, 6 and 12 months of enrollment for safety analysis.Includes the following parameters:urinary bilirubin,urinary ketone bodies,blood,urinary white blood cells,urinary red blood cells,urinary sugar,urinary protein,urinary cast.

Full Information

First Posted
May 16, 2023
Last Updated
June 16, 2023
Sponsor
Children's Hospital of Chongqing Medical University
Collaborators
Anhui Provincial Children's Hospital, Baoji Maternity and Child Healthcare Hospital, Chengdu Women's and Children's Central Hospital, Guiyang Maternity and Child Health Care Hospital, Guangzhou Women and Children's Medical Center, Hunan Children's Hospital, Jiangxi Maternal and Child Health Hospital, Kunming Children's Hospital, Nanjing Maternity and Child Health Care Hospital, Children's Hospital of The Capital Institute of Pediatrics, Xianyang Children's Hospital, Nestle Health Science
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1. Study Identification

Unique Protocol Identification Number
NCT05911893
Brief Title
the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
Acronym
EHCONSGDMC
Official Title
the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 30, 2023 (Anticipated)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Chongqing Medical University
Collaborators
Anhui Provincial Children's Hospital, Baoji Maternity and Child Healthcare Hospital, Chengdu Women's and Children's Central Hospital, Guiyang Maternity and Child Health Care Hospital, Guangzhou Women and Children's Medical Center, Hunan Children's Hospital, Jiangxi Maternal and Child Health Hospital, Kunming Children's Hospital, Nanjing Maternity and Child Health Care Hospital, Children's Hospital of The Capital Institute of Pediatrics, Xianyang Children's Hospital, Nestle Health Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to investigate the effect of high caloric oral nutritional supplements on body proportion, weight, linear growth pattern, neuropsychological development level and related health aspects (gut health, immune function, quality of life, etc.) in participants aged 1 to 3 years who are malnourished (underweight and wasting),as well as to evaluate the safety of applying high caloric oral nutritional supplements. Participants will receive nutritional education and daily high caloric oral nutritional supplements(experimental group),or will receive nutritional education and dietary instruction(control group).This study may provide data to support the development of clinical intervention strategies for malnourished Chinese children.
Detailed Description
Background:Growth and development is an important indicator of children's health and nutritional status, and nutrition is the most important material basis for growth and development. The prevention and treatment of malnutrition in children can be achieved by choosing whole nutritional formulas for special medical purposes as oral nutritional supplements (ONS), which has been confirmed by some overseas clinical studies to promote the growth benefit of malnourished children, but no multicenter clinical study has been conducted in China on the effect of ONS on the improvement of growth and development of malnourished Chinese children. Objective and significance: To investigate the effects of high caloric ONS on body proportion, weight, linear growth pattern, neuropsychological development level and related health aspects (gut health, immune function, quality of life, etc.) in children, as well as to evaluate the safety of applying high caloric ONS, and to provide data to support the development of clinical intervention strategies for malnourished Chinese children. Research design:A multicenter, randomized, controlled clinical trial design method is used to randomize children who meet the inclusion criteria into the experimental and control groups using a competitive entry method. The test group is given nutritional education and high caloric ONS (which can supplement 30% of the energy requirement), while the control group is given nutritional education and dietary instruction.Participants are followed up at 0, 1,2, 3, 6, and 12 months of enrollment. The investigators will collect dietary diaries, physical indicators, developmental quotient scores, quality of life measures, gut health, infectious disease-related questionnaires and safety indicators (blood biochemical indicators, urine routine) from children in both groups to comprehensively assess the effect of high caloric ONS intervention on physical growth, neuropsychological development levels and related aspects (gut health, immune function, quality of life, etc.) of malnourished children, as well as to conduct safety analyses. Sample size:According to similar studies to date, a total of 800 people are recommended for this study. Statistical analysis: Statistical analysis is performed using SAS 9.4. For continuous variables (height, weight, BMI-Z score, DQ score, etc.), statistical descriptions are performed using mean and standard deviation (conforming to normal distribution) or median and interquartile range (IQR); for categorical variables, statistical descriptions are performed using frequency and percentage; for the main efficacy indicators, mixed-effects models are used for efficacy evaluation indicators according to the principle of adjusted intentionality analysis (mITT). For the safety evaluation, the number, frequency and incidence of adverse events and reactions are calculated, and the positive abnormal changes of laboratory biochemical indexes such as blood routine, urine routine, liver and kidney function are counted. p value < 0.05 is considered statistically significant. Ethical matters and data protection: The guardians of the children participating in the study will sign an informed consent form. This study is approved by the local ethics committee. Patients' names will be abbreviated and study data will be assigned a code which will then be provided to the investigator. Parental authorization for patient health information will remain in effect until the study is completed. After that, private information will be removed from the study records by the researcher.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Child, Malnourishment, Nutritional Deficiency, Undernutrition
Keywords
Oral Nutritional Supplements, Physique Growth, Neuropsychological Development

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants aged 1 to 3 years who are malnourished (underweight and wasting) are randomly divided into an experimental group and a control group. The experimental group is given nutritional education and high-energy total nutrition formula, while the control group is given nutritional education and dietary guidance. At the 1-month, 2-month, 3-month, and 6-month follow-ups of enrollment, children in the control group are transferred to the trial group if the assessment revealed that they are unable to achieve ≥75% of their predicted nutritional requirements through dietary modification or their rate of weight gain do not improve, according to the study design principles of the stepped wedge cluster trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high caloric oral nutritional supplements group
Arm Type
Experimental
Arm Description
Participants aged 1 to 3 years who are malnourished (underweight and wasting). They will receive nutritional education,dietary instruction and daily high caloric oral nutritional supplements for 12 months.
Arm Title
nutritional education and dietary guidance group
Arm Type
Active Comparator
Arm Description
Participants aged 1 to 3 years who are malnourished (underweight and wasting). They will receive nutrition education and dietary instruction.
Intervention Type
Dietary Supplement
Intervention Name(s)
high caloric oral nutritional supplements
Other Intervention Name(s)
high-energy total nutrition formula
Intervention Description
High caloric oral nutritional supplements (which can supplement 30% of the energy requirement) is given daily, and the recommended amount of energy and protein is referred to the 2013 Chinese Dietary Nutrient Reference Intake Table. At 6 months of enrollment, participants will be asked to evaluate whether to continue feeding according to the experimental group protocol or to stop to ensure proper nutritional intake.
Intervention Type
Behavioral
Intervention Name(s)
nutritional education
Intervention Description
After enrollment,health education information is pushed approximately every 4 weeks through the WeChat platform or/and short text messages to parents.
Intervention Type
Behavioral
Intervention Name(s)
dietary guidance
Intervention Description
At follow-up visits at 0, 1, 2, 3, 6,and 12 months after enrollment, a professionally trained pediatrician give the participant's guardian dietary instructions appropriate to the age stage and physical condition of the child. Each session lasts approximately 10 minutes.
Primary Outcome Measure Information:
Title
BMI for Age Z-score(BAZ)
Description
Trained research assistants or health care practitioners obtain weight in kilograms and height in centimeters (mean of 3 consecutive measurements). Height and weight will be combined to report BMI in kg/m^2.Then, the BAZ is calculated using WHO2011v3.2.2 software.
Time Frame
at 6 months of enrollment
Secondary Outcome Measure Information:
Title
Dietary Diary
Description
Participants provide a dietary diary over an average two-day period through a WeChat app each visit. The app prompts participants to record and estimate details of all meals and snacks they consumed, especially formula used in the study.
Time Frame
at 0, 1, 2, 3, 6 and 12 months of enrollment
Title
BMI for Age Z-score(BAZ)
Description
Trained research assistants or health care practitioners obtain weight in kilograms and height in centimeters (mean of 3 consecutive measurements). Height and weight will be combined to report BMI in kg/m^2.Then, the BAZ is calculated using WHO2011v3.2.2 software.
Time Frame
at 0, 1, 2, 3 and 12 months of enrollment
Title
Weight for Age Z-score(WAZ)
Description
Trained research assistants or health care practitioners obtain weight in kilograms using a standardized approach. Weight is measured using a precision digital scale or mechanical scale(mean of 3 consecutive measurements). Then, the WAZ is calculated using WHO2011v3.2.2 software.
Time Frame
at 0, 1, 2, 3, 6 and 12 months of enrollment
Title
Height for Age Z-score(HAZ)
Description
Trained research assistants or health care practitioners obtain height in centimeters using a standardized approach. Height is measured with a calibrated stadiometer(mean of 3 consecutive measurements). Then, the HAZ is calculated using WHO2011v3.2.2 software.
Time Frame
at 0, 1, 2, 3, 6 and 12 months of enrollment
Title
Gesell Developmental Scale Test
Description
Mainly assesses participants in 5 areas:adaptive behavior, gross motor, fine motor, language behavior,personal-social behavior, the evaluation finally calculates the developmental quotient (DQ) of each area. Diagnostic criteria: DQ is more than or equal to 86 is normal, DQ is marginal between 76 and 85, DQ is mild mental retardation between 55 and 75, DQ is moderate mental retardation between 40 and 54, DQ is severe mental retardation between 25 and 39, and DQ is less than or equal to 25 is extremely severe mental retardation.
Time Frame
at 0, 6, and 12 months of enrollment
Title
Infants - Junior High School Students Social Competence Test (S-M test)
Description
The scale, derived from the revised version of the Japanese Social Competence test (S-M test) and revised by a Chinese researcher, is applicable to children from 6 months of age to 14 years of age and includes 132 items in 6 sections with 7 starting ages, which are filled in item by item by parents or daily caregivers according to the appropriate age, with ≥10 being normal.
Time Frame
at 0, 6, and 12 months of enrollment
Title
Pediatric Quality of Life Inventory (PedsQL)
Description
The quality of life of the participants is assessed using the Pediatric Quality of Life Inventory.The Infant Scale or Generic Core Scales is completed according to age.Scores are transformed on a scale from 0 to 100,with higher scores indicating better quality of life.
Time Frame
at 0, 6, and 12 months of enrollment
Title
the Chinese version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Description
The quality of life of parents is assessed using the WHOQOL-BREF.The WHOQOL-BREF, comprises 26 items, two general items and 24 others, across the following four domains: physical (7 items), psychological (6 items), social (3 items), and environmental (8 items).Calculate the average score of all items in each domain, converted into a score of 4 to 20 or 0 to100 by two algorithms,with higher scores indicating better quality of life.
Time Frame
at 0, 6 and 12 months of enrollment
Title
Gut Health Questionnaire
Description
A questionnaire is used to understand gut health, including entries on the Bristol Stool Scale (to assess stool status), the average number of bowel movements per day, and the frequency of bloating and abdominal pain.
Time Frame
at 0, 1,3, 6, and 12 months of enrollment
Title
Infectious Diseases Related Questionnaire
Description
A infectious disease-related questionnaire is used to understand immune function, including the number and duration of upper respiratory tract infections, infectious diarrhea.
Time Frame
at 0, 1,3, 6, and 12 months of enrollment
Title
Blood Routine Test
Description
Blood routine test is completed at 0, 6 and 12 months of enrollment for safety analysis.Includes the following parameters:white blood cell count,red blood cell count,hemoglobin,mean corpuscular hemoglobin concentration,platelet,standard deviation in red cell distribution width,coefficient variation of red blood cell volume distribution width,platelet distribution width,mean platelet volume,platelet larger cell ratio,thrombocytocrit,neutrophil ratio,lymphocyte ratio,monocyte ratio,eosinophil ratio,basophil ratio,neutrophil count,lymphocyte count,monocyte count,eosinophil count,basophil count.
Time Frame
at 0, 6 and 12 months of enrollment
Title
Liver Function Test
Description
Liver function test is completed at 0, 6 and 12 months of enrollment for safety analysis.Includes the following parameters:total protein,albumin,globulin,alanineamino transferase,aspartate amino transferase,bilirubin,direct bilirubin,total bile acid,alkaline phosphatase,amma-glutamyl transpeptidase.
Time Frame
at 0, 6 and 12 months of enrollment
Title
Renal Function Test
Description
Renal function test is completed at 0, 6 and 12 months of enrollment for safety analysis.Includes the following parameters:creatinine,blood urea nitrogen.
Time Frame
at 0, 6 and 12 months of enrollment
Title
Urine Routine Test
Description
Urine routine test is completed at 0, 6 and 12 months of enrollment for safety analysis.Includes the following parameters:urinary bilirubin,urinary ketone bodies,blood,urinary white blood cells,urinary red blood cells,urinary sugar,urinary protein,urinary cast.
Time Frame
at 0, 6 and 12 months of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 1-3 years BMI for Age Z-score<-2 Height-for-age z score<-2 Total daily energy intake<75% of recommended nutrient intake The child's guardian is willing to participate in this study and sign an informed consent form. Exclusion Criteria: Chronic or severe infectious disease (e.g., chronic hepatitis, HIV or tuberculosis infection) Certain congenital or genetic diseases affecting physical growth and development (congenital heart disease, Down's syndrome, infantile anorexia nervosa, etc.), malignancies and use of drugs (diuretics, appetite stimulants, steroids and growth hormones, etc.) Severe gastrointestinal disorders (e.g., celiac disease, short bowel syndrome, inflammatory bowel disease, etc.) Acute and chronic respiratory/digestive tract infections within 2 weeks prior to enrollment Allergy or contraindication to any of the ingredients in the high-energy total nutrition formula used in this study Have used high-energy enteral nutrition preparations for the last 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Chen, doctor
Phone
136 7762 0103
Ext
+86
Email
chenli2012@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Chen, doctor
Organizational Affiliation
Children's Hospital of Chongqing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Anhui Provincial Children's Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ya Wang, master's degree
Phone
13855150595
Ext
+86
Email
22891588@qq.com
Facility Name
Children's Hospital of The Capital Institute of Pediatrics
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Wang, MD
Phone
13501362346
Ext
+86
Email
caroldoctor@126.com
Facility Name
Growth, Development and Mental health of Children and Adolescence Center
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400014
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Chen, MD
Phone
(+86)136 7762 0103
Ext
+86
Email
chenli2012@126.com
Facility Name
Guangzhou Women and Children's Medical Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510200
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Hu, master's degree
Phone
13560366657
Ext
+86
Email
yayayan1979@163.com
Facility Name
Guiyang Maternity and Child Health Care Hospital
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Luo, MD
Phone
18585011079
Ext
+86
Email
718410342@qq.com
Facility Name
Hunan Children's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410007
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhong, bachelor's degree
Phone
13873170189
Ext
+86
Email
zhongyan@163.com
Facility Name
Nanjing Maternity and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Chi, MD
Phone
13813875862
Ext
+86
Email
264601855@qq.com
Facility Name
Jiangxi Maternal and Child Health Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Xu, bachelor's degree
Phone
13879112716
Ext
+86
Email
278938835@qq.com
Facility Name
Baoji Maternity and Child Healthcare Hospital
City
Baoji
State/Province
Shanxi
ZIP/Postal Code
721000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueqin Li, master's degree
Phone
15229681332
Ext
+86
Email
85581703@qq.com
Facility Name
Xianyang Children's Hospital
City
Xianyang
State/Province
Shanxi
ZIP/Postal Code
712000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongxia Yan, bachelor's degree
Phone
15909263117
Ext
+86
Email
1142179306@qq.com
Facility Name
Chengdu Women's and Children's Central Hospital,School of Medicine,University of Electronic Science and Technology of China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610091
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lan Zhang, master's degree
Phone
13982156971
Ext
+86
Email
893279990@qq.com
Facility Name
Kunming Children's Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Ling, bachelor's degree
Phone
13888594860
Ext
+86
Email
lingyu@etyy.cn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data is confidential during the study.
Citations:
PubMed Identifier
30413417
Citation
Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, Dixon-Woods M, Aldcroft A, Doussau A, Grayling M, Kristunas C, Goldstein CE, Campbell MK, Girling A, Eldridge S, Campbell MJ, Lilford RJ, Weijer C, Forbes AB, Grimshaw JM. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. 2018 Nov 9;363:k1614. doi: 10.1136/bmj.k1614.
Results Reference
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the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children

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