Infant, Premature, DiseasesNCT01731613
Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants
A study testing human milk fortifier in people with Infant, Premature, Diseases, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow. Read more about this study
- Who is it for?
- Ages 10 to 40 days
- Conditions the study is for
- Infant, Premature, Diseases
- What is being tested?
- human milk fortifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Aug 2017
- 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 10 to 40 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Less than 34 weeks gestational age at birth
- Birth weight within 800-1800 grams
- Exclusively or mostly breastfed (greater than 80% if the feeding volume)
- Tolerated enteral feedings of 60 ml/kg/d
- Remain in the Neonatal Intensive Care Unit at least 14 days prior to hospital discharge,remain in the Neonatal Intensive Care Unit at least 10 days after enrollment
- Signed Informed Consent
Who cannot join
- Small for gestational age
- Infants currently receiving ventilation therapy
- Major congenital malformations
- Suspected or documented systemic or congenital infections
- Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth
- Severe intraventricular hemorrhage (greater than grade II) or periventricular leukomalacia
- Suspected or documented maternal substance abuse
- Infants currently receiving glucocorticoids or infants who have received glucocorticoids within the past 28 days
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.
Read the detailed description
A total of 60 premature infants who will be randomized to receive either a standard fortification regimen (n=30) or an adjustable fortification regimen (n=30). The adjustable fortification regimen encompasses increasing / decreasing the amount of fortifier and adding supplemental protein guided by periodic determinations of the protein concentration in human milk (PCHM), body weight and blood urea nitrogen (BUN). Growth rate, tolerance of enteral feeding, days to achieve 100kcal/kg/d through enteral feeding, length of parenteral nutrition and NICU stays will be measured and compared between groups.
- Conditions
- Infant, Premature, Diseases
- Being tested
- human milk fortifier
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human milk fortifierDietary supplement
Also called HMF
Then fortification with human milk fortifier will be initiated at different levels according to the body weight of infants, the protein concentration of human milk and blood urea nitrogen
| Study group | Role | What they receive |
|---|---|---|
| Standard Fortification | Active comparator | receive human milk fortified with human milk fortifier(HMF) in the standard amount (4 packs /100 ml of HM) throughout the study Receives: Dietary Supplement: human milk fortifier |
| Adjustable fortification | Experimental | encompasses increasing/decreasing the amount of human milk fortifier(HMF) and adding supplemental protein guided by periodic determinations of the protein concentration of human milk (PCHM), body weight, blood urea nitrogen(BUN) Receives: Dietary Supplement: human milk fortifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach 100kcal/kg/d of enteral nutrition
Days to reach 100kcal/kg/d of enteral nutrition
Measured: participants will be followed until discharge, an expected average of 2 weeks
The weight gain velocity during hospitalization
The weight gain velocity(g/kg/d)
Measured: participants will be followed until discharge, an expected average of 2 weeks
Secondary outcomes (3)
The protein and energy ratio of enteral nutrition each week after enrollment
The protein and energy ratio(g/100kcal)
Measured: participants will be followed until discharge, an expected average of 2 weeks
Time to reach 2000g of body weight
Days to reach 2000g of body weight
Measured: participants will be followed until discharge, an expected average of 2 weeks
metabolic indicators after enrollment, including BUN,prealbumin, albumin
BUN(mmol/L), prealbumin(mg/L), albumin(g/L)
Measured: participants will be followed until discharge, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Responsible party
- Principal investigator, Danhua Wang, Peking Union Medical College Hospital
- Investigators
- Danhua Wang, Professor, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731613
- Sponsor's protocol ID
- 8648
- Status last verified
- Nov 2017
- First submitted
- 5 Nov 2012
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants
- ClinicalTrials.gov ID
- NCT01731613
- Acronym / sponsor ID
- 8648
- Conditions
- Infant, Premature, Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Study start
- Aug 2012 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Nov 2012 (estimated)
- 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 clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.
Detailed description
A total of 60 premature infants who will be randomized to receive either a standard fortification regimen (n=30) or an adjustable fortification regimen (n=30). The adjustable fortification regimen encompasses increasing / decreasing the amount of fortifier and adding supplemental protein guided by periodic determinations of the protein concentration in human milk (PCHM), body weight and blood urea nitrogen (BUN). Growth rate, tolerance of enteral feeding, days to achieve 100kcal/kg/d through enteral feeding, length of parenteral nutrition and NICU stays will be measured and compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Fortification | Active comparator | Dietary Supplement: human milk fortifierreceive human milk fortified with human milk fortifier(HMF) in the standard amount (4 packs /100 ml of HM) throughout the study |
| Adjustable fortification | Experimental | Dietary Supplement: human milk fortifierencompasses increasing/decreasing the amount of human milk fortifier(HMF) and adding supplemental protein guided by periodic determinations of the protein concentration of human milk (PCHM), body weight, blood urea nitrogen(BUN) |
Who may qualify
- Ages
- 10 to 40 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Less than 34 weeks gestational age at birth
- Birth weight within 800-1800 grams
- Exclusively or mostly breastfed (greater than 80% if the feeding volume)
- Tolerated enteral feedings of 60 ml/kg/d
- Remain in the Neonatal Intensive Care Unit at least 14 days prior to hospital discharge,remain in the Neonatal Intensive Care Unit at least 10 days after enrollment
Key exclusion criteria (8 listed)
- Small for gestational age
- Infants currently receiving ventilation therapy
- Major congenital malformations
- Suspected or documented systemic or congenital infections
- Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth
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 |
|---|---|---|
| human milk fortifierAlso: HMFThen fortification with human milk fortifier will be initiated at different levels according to the body weight of infants, the protein concentration of human milk and blood urea nitrogen | Dietary supplement | Adjustable fortification, Standard Fortification |
Primary outcome
Time to reach 100kcal/kg/d of enteral nutrition
Time frame: participants will be followed until discharge, an expected average of 2 weeks
Days to reach 100kcal/kg/d of enteral nutrition
The weight gain velocity during hospitalization
Time frame: participants will be followed until discharge, an expected average of 2 weeks
The weight gain velocity(g/kg/d)
3 secondary outcomes
The protein and energy ratio of enteral nutrition each week after enrollment
Time frame: participants will be followed until discharge, an expected average of 2 weeks
Time to reach 2000g of body weight
Time frame: participants will be followed until discharge, an expected average of 2 weeks
metabolic indicators after enrollment, including BUN,prealbumin, albumin
Time frame: participants will be followed until discharge, an expected average of 2 weeks
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 28 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Infant, Premature, Diseases
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Danhua Wang, Professor principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human milk fortifier in people with Infant, Premature, Diseases, run by Peking Union Medical College Hospital at 1 site 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 6 inclusion and 8 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 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Time to reach 100kcal/kg/d of enteral nutrition (time frame: participants will be followed until discharge, an expected average of 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2017.