Preterm InfantNCT04283799
Using a New Human Milk Fortifier to Optimize Feeding
A study testing A new human milk fortifier in people with Preterm Infant and Growth, run by Children's Hospital of Fudan University at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Preterm Infant, Growth
- What is being tested?
- A new human milk fortifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 7 sitesChina
- Study dates
- 16 Mar 2020to 23 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Nanjing Maternal and Child Health Hospital
Nanjing, Jiangsu, 210004
Children's Hospital of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200062
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Shanghai First Maternity and Infant Hosipital
Shanghai, Shanghai Municipality, 200126
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, 200127
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Using a New Human Milk Fortifier to Optimize Human Milk Feeding in Very Preterm Infants, a Multicenter Clinical Trial
This study aims to compare the safety and efficacy of a new HMF and those of other HMF used before in very preterm infants.
Read the 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.
- Conditions
- Preterm Infant, Growth
- Being tested
- A new human milk fortifier
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A new human milk fortifierDietary supplement
Contents of protein, protein/energy ratio, moderate hydrolysis of whey protein, medium-chain fatty acid are increased in the new HMF
| Study group | Role | What they receive |
|---|---|---|
| The new HMF group | Experimental | 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. Receives: Dietary Supplement: A new human milk fortifier |
| Other HMF group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the procedure
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From birth to discharge, an average of 30 days
Incidence of retinopathy of prematurity (ROP)
ROP is diagnosed by ophthalmologists according to fundus examination.
Measured: From birth to discharge, an average of 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start16 Mar 2020
- Primary completion23 Apr 2021
- Study completion23 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Cao, Ph.D., M.D., Principal investigator, Children's Hospital of Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283799
- Sponsor's protocol ID
- NES-SR
- Status last verified
- Jun 2021
- First submitted
- 23 Feb 2020
- Last updated
- 9 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han J, Zhang L, Zhang R, Han S, Zhu J, Hu X, Sun J, Qiu G, Li Z, Yan W, Xie L, Ye X, Gong X, Li L, Bei F, Liu C, Cao Y. Using a new human milk fortifier to optimize human milk feeding among very preterm and/or very low birth weight infants: a multicenter study in China. BMC Pediatr. 2024 Jan 19;24(1):61. doi: 10.1186/s12887-024-04527-2.
PubMed 38243173
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a New Human Milk Fortifier to Optimize Human Milk Feeding in Very Preterm Infants, a Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT04283799
- Acronym / sponsor ID
- NES-SR
- Conditions
- Preterm Infant, Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the safety and efficacy of a new HMF and those of other HMF used before in very preterm infants.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The new HMF group | Experimental | Dietary Supplement: A new human milk fortifierVery 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. |
| Other HMF group | No intervention | –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. |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A new human milk fortifierContents of protein, protein/energy ratio, moderate hydrolysis of whey protein, medium-chain fatty acid are increased in the new HMF | Dietary supplement | The new HMF group |
Primary outcome
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.
21 secondary outcomes
Growth velocity of head circumference
Time frame: During the procedure
Incidence of feeding intolerance
Time frame: From the start day of feeding to discharge，an average of 50 days
Time to achieve full enteral feeding
Time frame: During the hospitalization，an average of 20 days
The changes of blood hemoglobin
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum albumin
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum proalbumin
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum potassium
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum sodium
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum phosphorus
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The changes of serum calcium
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum alkaline phosphatase
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of blood urea nitrogen
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The changes of cholesterol
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The Change of triglyceride.
Time frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
Incidence of abnormal body temperature
Time frame: During the period using HMF, an average of 30 days
Incidence of apnea
Time frame: During the period using HMF, an average of 30 days
Incidence of abnormal heart rate
Time frame: During the period using HMF, an average of 30 days
Incidence of necrotizing enterocolitis (NEC)
Time frame: From birth to discharge, an average of 20 days
Incidence of bronchopulmonary dysplasia (BPD)
Time frame: From birth to discharge, an average of 40 days
Incidence of sepsis
Time frame: From birth to discharge, an average of 30 days
Incidence of retinopathy of prematurity (ROP)
Time frame: From birth to discharge, an average of 40 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Derived from this study: PubMed 38243173Han J, Zhang L, Zhang R, Han S, Zhu J, Hu X, Sun J, Qiu G, Li Z, Yan W, Xie L, Ye X, Gong X, Li L, Bei F, Liu C, Cao Y. Using a new human milk fortifier to optimize human milk feeding among very preterm and/or very low birth weight infants: a multicenter study in China. BMC Pediatr. 2024 Jan 19;24(1):61. doi: 10.1186/s12887-024-04527-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun Cao, Ph.D., M.D. principal investigator
Children's Hospital of Fudan University, Shanghai, China
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A new human milk fortifier in people with Preterm Infant and Growth, run by Children's Hospital of Fudan University at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth velocity of weight (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04283799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.