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Using a New Human Milk Fortifier to Optimize Feeding

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ClinicalTrials.gov Identifier: NCT04283799
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

Brief Summary:
This study aims to compare the safety and efficacy of a new HMF and those of other HMF used before in very preterm infants.

Condition or disease Intervention/treatment Phase
Preterm Infant Growth Dietary Supplement: A new human milk fortifier Not Applicable

Detailed Description:
Infants with fortified human milk feeding have the same rate of growth, lower incidence of nosocomial infections and feeding intolerance compared to those with formula feeding during hospitalization. However, the currently human milk fortifiers (HMF) have some nutritional components defects to meet the needs of very preterm infants. New HMF provide higher protein and fat, which are safe and well tolerate to use in preterm infants. Study on safety and efficacy of the new HMF is insufficient in Chinese preterm infant population. Our aims are to compare the safety and efficacy of a new HMF and other HMF used before in very preterm infants. Very low preterm infants with birth weights of 1000-1499g and gestational age 28+0 weeks to 31 + 6 weeks are included. Infants feeding with new HMF are in the experimental group. Infants feeding with other HMF are in the control group, a historically control group. Physical growth, nutritional indexes, incidence of feeding intolerance, and time to achieve full enteral feeding are compared between the two groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using a New Human Milk Fortifier to Optimize Human Milk Feeding in Very Preterm Infants, a Multicenter Clinical Trial
Actual Study Start Date : March 16, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
Experimental: The new HMF group
Very preterm infants tolerating 80mL/kg/day of enteral feeding for >24 hours are started to receive the new human milk fortifier. Study procedure is from the first day of full-strength fortification feeding to the 21th days of that.
Dietary Supplement: A new human milk fortifier
Contents of protein, protein/energy ratio, moderate hydrolysis of whey protein, medium-chain fatty acid are increased in the new HMF

No Intervention: Other HMF group
This group is a historical control group using the other HMF. Infants with similar gestational age, birth weight, feeding start time and length of hospitalization are enrolled into the control group.



Primary Outcome Measures :
  1. Growth velocity of weight [ Time Frame: During the procedure ]
    Weight is tested daily using the same electronic weighing scale in the different study units. Growth velocity of weight is described in g/day.


Secondary Outcome Measures :
  1. Growth velocity of head circumference [ Time Frame: During the procedure ]
    Head circumference is measured weekly using a nonelastic measuring tape placed over the largest circumference of the skull weekly. Growth velocity is described in cm/week.

  2. Incidence of feeding intolerance [ Time Frame: From the start day of feeding to discharge,an average of 50 days ]
    Feeding intolerance is defined as feeds being withheld for 24 hours or more due to concerns related to feeding.

  3. Time to achieve full enteral feeding [ Time Frame: During the hospitalization,an average of 20 days ]
    Infants tolerating 120mL/ kg/day of enteral feeding for >24 hours are defined as full enteral feeding.

  4. The changes of blood hemoglobin [ Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding. ]
    Blood hemoglobin is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as g/dL.

  5. The change of serum albumin [ Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding. ]
    Serum albumin is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as g/L.

  6. The change of serum proalbumin [ Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding. ]
    Serum proalbumin is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mg/L.

  7. The change of serum potassium [ Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding. ]
    Serum potassium is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.

  8. The change of serum sodium [ Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding. ]
    Serum sodium is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.

  9. The change of serum phosphorus [ Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding. ]
    Serum phosphorus is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.

  10. The changes of serum calcium [ Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding. ]
    Serum calcium is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.

  11. The change of serum alkaline phosphatase [ Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding. ]
    Serum alkaline phosphatase is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as U/L.

  12. The change of blood urea nitrogen [ Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding. ]
    Blood urea nitrogen is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.

  13. The changes of cholesterol [ Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding. ]
    Cholesterol is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.

  14. The Change of triglyceride. [ Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding. ]
    Triglyceride is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.

  15. Incidence of abnormal body temperature [ Time Frame: During the period using HMF, an average of 30 days ]
    Axillary temperature is tested by nurses using clinical electronic thermometers once every four hours. Either low body temperature ( <35℃) or high body temperature ( >37.5℃) is abnormal body temperature.

  16. Incidence of apnea [ Time Frame: During the period using HMF, an average of 30 days ]
    Apnea is defined as premature infants with respiratory arrest of more than 20 seconds, accompanied by a slow heartbeat, purple or pale skin, and decreased muscle tone.

  17. Incidence of abnormal heart rate [ Time Frame: During the period using HMF, an average of 30 days ]
    Either heart rate increase (>180/min) or decrease (<90/min) is defined as abnormal heart rate.

  18. Incidence of necrotizing enterocolitis (NEC) [ Time Frame: From birth to discharge, an average of 20 days ]
    NEC is diagnosed according to the Bell's grade scale.

  19. Incidence of bronchopulmonary dysplasia (BPD) [ Time Frame: From birth to discharge, an average of 40 days ]
    BPD is defined as oxygen requirement at 36 weeks' postconceptional age.

  20. Incidence of sepsis [ Time Frame: From birth to discharge, an average of 30 days ]
    Both culture confirmed sepsis and clinical sepsis are defined as sepsis in this study.

  21. Incidence of retinopathy of prematurity (ROP) [ Time Frame: From birth to discharge, an average of 40 days ]
    ROP is diagnosed by ophthalmologists according to fundus examination.



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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants with gestational age between 28+0 weeks to 31+6 weeks, and 1000g≤ birth weight<1500g;
  • Delivered in the study centers or transfer to the study centers within 24 hours after birth;
  • Own mother's milk or human milk bank were available;
  • Only one of the twins is selected in this study;
  • Informed consent has been obtained.

Exclusion Criteria:

  • Severe congenital malformations, severe asphyxia, intracranial hemorrhage and other diseases;
  • Small for gestational age infants (birth weight below the 10th percentile of the reference, Fenton premature infant growth chart (2013));
  • Enteral feeding is not tolerated in 14 days after birth;
  • Infants who have participated in other clinical trials within 1 month;
  • Other conditions not suitable for this study.

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): NCT04283799


Contacts
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Contact: Junyan Han +8613524675569 jyhan17@fudan.edu.cn

Locations
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China, Beijing
Peking Union Medical College Hospital Not yet recruiting
Peking, Beijing, China, 100730
Contact: Zhenghong Li, Ph.D.    +8618501309801      
China, Jiangsu
Nanjing Maternal and Child Health Hospital Not yet recruiting
Nanjing, Jiangsu, China, 210004
Contact: Shuping Han, Ph.D.    +8613585204767      
China, Shanghai
Obstetrics and Gynecoloy Hospital of Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200011
Contact: Jimei Wang, Ph.D.    +8613817000825      
Children's Hospital of Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200062
Contact: Gang Qiu, Ph.D.    +8602152976123      
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: Lijuan Xie, Ph.D.    +8613816153616      
Shanghai First Maternity and Infant Hosipital Recruiting
Shanghai, Shanghai, China, 200126
Contact: Xuefeng Hu, Ph.D.    +8613371985136      
Shanghai Children's Medical Center Recruiting
Shanghai, Shanghai, China, 200127
Contact: Jianhua Sun, Ph.D.    +8618930830602      
Children's Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 201102
Contact: Yun Cao, Ph.D., M.D.         
Contact    +8602164931160    yuncao@fudan.edu.cn   
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Principal Investigator: Yun Cao, Ph.D., M.D. Children's Hospital of Fudan University, Shanghai, China
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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT04283799    
Other Study ID Numbers: NES-SR
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications