This study aims to compare the safety and efficacy of a new HMF and those of other HMF used before in very preterm infants.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
276
Contents of protein, protein/energy ratio, moderate hydrolysis of whey protein, medium-chain fatty acid are increased in the new HMF
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Nanjing Maternal and Child Health Hospital
Nanjing, Jiangsu, China
Children's Hospital of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Growth velocity of weight
Weight is tested daily using the same electronic weighing scale in the different study units. Growth velocity of weight is described in g/day.
Time frame: During the procedure
Growth velocity of head circumference
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.
Time frame: During the procedure
Incidence of feeding intolerance
Feeding intolerance is defined as feeds being withheld for 24 hours or more due to concerns related to feeding.
Time frame: From the start day of feeding to discharge，an average of 50 days
Time to achieve full enteral feeding
Infants tolerating 120mL/ kg/day of enteral feeding for \>24 hours are defined as full enteral feeding.
Time frame: During the hospitalization，an average of 20 days
The changes of blood hemoglobin
Blood hemoglobin is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as g/dL.
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum albumin
Serum albumin is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as g/L.
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
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Shanghai, Shanghai Municipality, China
Shanghai First Maternity and Infant Hosipital
Shanghai, Shanghai Municipality, China
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
The change of serum proalbumin
Serum proalbumin is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mg/L.
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum potassium
Serum potassium is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum sodium
Serum sodium is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum phosphorus
Serum phosphorus is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The changes of serum calcium
Serum calcium is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum alkaline phosphatase
Serum alkaline phosphatase is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as U/L.
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of blood urea nitrogen
Blood urea nitrogen is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The changes of cholesterol
Cholesterol is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The Change of triglyceride.
Triglyceride is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
Incidence of abnormal body temperature
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.
Time frame: During the period using HMF, an average of 30 days
Incidence of apnea
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.
Time frame: During the period using HMF, an average of 30 days
Incidence of abnormal heart rate
Either heart rate increase (\>180/min) or decrease (\<90/min) is defined as abnormal heart rate.
Time frame: During the period using HMF, an average of 30 days
Incidence of necrotizing enterocolitis (NEC)
NEC is diagnosed according to the Bell's grade scale.
Time frame: From birth to discharge, an average of 20 days
Incidence of bronchopulmonary dysplasia (BPD)
BPD is defined as oxygen requirement at 36 weeks' postconceptional age.
Time frame: From birth to discharge, an average of 40 days
Incidence of sepsis
Both culture confirmed sepsis and clinical sepsis are defined as sepsis in this study.
Time frame: From birth to discharge, an average of 30 days
Incidence of retinopathy of prematurity (ROP)
ROP is diagnosed by ophthalmologists according to fundus examination.
Time frame: From birth to discharge, an average of 40 days