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Completed

NCT Number: NCT04283799

Using a New Human Milk Fortifier to Optimize Feeding

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

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Key information

Conditions

Preterm Infant Female Urogenital Diseases and Pregnancy Complications Growth Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A new human milk fortifier

Dietary Supplement

Contents of protein, protein/energy ratio, moderate hydrolysis of whey protein, medium-chain fatty acid are increased in the new HMF

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

Using a New Human Milk Fortifier to Optimize Human Milk Feeding in Very Preterm Infants, a Multicenter Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2020
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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