Late Premature InfantsNLPNCT02605577
Research of Systemic Management for Late Preterm Infants Nutrition in China
A study testing new systemic nutrition management protocol in people with Late Premature Infants and Systemic Nutritional Management, run by Peking Union Medical College Hospital.
Trial summary
The purpose of the project is to investigate the status of nutrition management of late preterm infants in the member hospitals in the Beijing association of preterm infants, and set up the systemic nutritional management of late preterm infants, Including parenteral nutrition and enteral feeding. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Late Premature Infants, Systemic Nutritional Management
- What is being tested?
- new systemic nutrition management protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- preterm infants with gestational age 34 weeks to 36 weeks and 6 days
Who cannot join
- preterm infants with gestational age<34 weeks or >36 weeks and 6 days
- abnormality of digestive system
- genetic and metablic disease
- severe congenital heart disease( with hemodynamic changes that influencing enteral feeding)
About this study
The purpose of the project is to investigate the status of nutrition management of late preterm infants in the member hospitals in the Beijing association of preterm infants, and set up the systemic nutritional management of late preterm infants, Including parenteral nutrition and enteral feeding. And to compare the differences of growth and complications of these infants between groupings applicationg and not applicating the systemic nutritional management of late preterm infants,and to validate its feasibility and validity.
Read the detailed description
The research content of the project includes three parts:
- Investigation on nutritional status of late preterm infants.
- Setting up systemic nutritional management of late preterm infants
- Comparing nutritional and growth status of the late preterm, short-term and long-term complications between the groups applicating and not applicating the systemic nutritional management of late pretern infants.
- Being tested
- new systemic nutrition management protocol
- Keywords
- late preterm infants, nutrition, systemic management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new systemic nutrition management protocolProcedure or surgery
a new established systemic nutrition management protocol
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | group of late preterm infants following "new systemic nutritional management protocol" during hospital stay,which including specific enteral and parenteral nutritional protocol and complication monitor, such as hyperglycemia,hypoglycemia,infection,hyperbilirubinemia and anemia(the intervention refers to this"new systemic nutritional management protocol" ) Receives: Procedure: new systemic nutrition management protocol |
| control group | No intervention | group of late preterm infants using current nutritional management protocol during hospital stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
days of postnatal life when enteral nutrition reaching 120kcal/kg/d
Measured: 29 months
weight gain(g/kg/week)
Measured: 29 months
length gain(cm/week)
Measured: 29 months
circumference gain(cm/week)
Measured: 29 months
Secondary outcomes (10)
days of postnatal life when reaching full enteral nutrion(d)
the incidence of complications of preterm infants
Measured: 29 months
proportion of breast milk feeding(%)
Measured: 29 months
days of postnatal life with the lowst weight during hospitalisation(d)
Measured: 29 months
the lowest weight during hospitalisation(g)
Measured: 29 months
days of postnatal life that regain birth weight(d)
Measured: 29 months
incidence of hyperglycemia(%)
Measured: 29 months
incidence of hypoglycemia(%)
Measured: 29 months
incidence of hypebilirubinemia(%)
Measured: 29 months
incidence of neonatal infection(%)
Measured: 29 months
incidence of neonatal anemia(%)
Measured: 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Premature InfantsStudies 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
- Care provider, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Peking University People's Hospital, Peking University Third Hospital, Beijing Children's Hospital, Capital Institute of Pediatrics, China, Beijing Obstetrics and Gynecology Hospital, Beijing Huaxin Hospital, Beijing Friendship Hospital, Beijing Ditan Hospital, Bayi Children's Hospital Affiliated to Beijing Military Gen Hospital, Beijing Shangdi Hospital, Beijing Tongzhou District Maternal and Child Health Hospital, Beijing Yanqing County Hospital, People's Hospital of Beijing Daxing District, Beijing Hospital, Civil Aviation General Hospital, Beijing Anzhen Hospital, Chinese PLA General Hospital, Beijing Haidian Maternal and Child Health Hospital, Beijing 302 Hospital, Beijing Chaoyang District Maternal and Child Health Hospital, China-Japan Friendship Hospital, The 306 Hospital of People's Liberation Army, Beijing Chao Yang Hospital, Navy General Hospital, Beijing
- Responsible party
- Principal investigator, Li zhenghong, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605577
- Sponsor's protocol ID
- SMFLPIN
- Acronym
- NLP
- Status last verified
- Dec 2015
- First submitted
- 6 Oct 2015
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Systemic Management for Late Preterm Infants Nutrition in China
- ClinicalTrials.gov ID
- NCT02605577
- Acronym / sponsor ID
- NLP / SMFLPIN
- Keywords
- late preterm infants, nutrition, systemic management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Peking University People's Hospital, Peking University Third Hospital, Beijing Children's Hospital, Capital Institute of Pediatrics, China, Beijing Obstetrics and Gynecology Hospital, Beijing Huaxin Hospital, Beijing Friendship Hospital, Beijing Ditan Hospital, Bayi Children's Hospital Affiliated to Beijing Military Gen Hospital, Beijing Shangdi Hospital, Beijing Tongzhou District Maternal and Child Health Hospital, Beijing Yanqing County Hospital, People's Hospital of Beijing Daxing District, Beijing Hospital, Civil Aviation General Hospital, Beijing Anzhen Hospital, Chinese PLA General Hospital, Beijing Haidian Maternal and Child Health Hospital, Beijing 302 Hospital, Beijing Chaoyang District Maternal and Child Health Hospital, China-Japan Friendship Hospital, The 306 Hospital of People's Liberation Army, Beijing Chao Yang Hospital, Navy General Hospital, Beijing
- Study start
- Jan 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Nov 2015 (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.
The purpose of the project is to investigate the status of nutrition management of late preterm infants in the member hospitals in the Beijing association of preterm infants, and set up the systemic nutritional management of late preterm infants, Including parenteral nutrition and enteral feeding. And to compare the differences of growth and complications of these infants between groupings applicationg and not applicating the systemic nutritional management of late preterm infants,and to validate its feasibility and validity.
Detailed description
The research content of the project includes three parts:
- Investigation on nutritional status of late preterm infants.
- Setting up systemic nutritional management of late preterm infants
- Comparing nutritional and growth status of the late preterm, short-term and long-term complications between the groups applicating and not applicating the systemic nutritional management of late pretern infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: new systemic nutrition management protocolgroup of late preterm infants following "new systemic nutritional management protocol" during hospital stay,which including specific enteral and parenteral nutritional protocol and complication monitor, such as hyperglycemia,hypoglycemia,infection,hyperbilirubinemia and anemia(the intervention refers to this"new systemic nutritional management protocol" ) |
| control group | No intervention | –group of late preterm infants using current nutritional management protocol during hospital stay |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- preterm infants with gestational age 34 weeks to 36 weeks and 6 days
Key exclusion criteria (4 listed)
- preterm infants with gestational age<34 weeks or >36 weeks and 6 days
- abnormality of digestive system
- genetic and metablic disease
- severe congenital heart disease( with hemodynamic changes that influencing enteral feeding)
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 |
|---|---|---|
| new systemic nutrition management protocola new established systemic nutrition management protocol | Procedure or surgery | experimental group |
Primary outcome
days of postnatal life when enteral nutrition reaching 120kcal/kg/d
Time frame: 29 months
weight gain(g/kg/week)
Time frame: 29 months
length gain(cm/week)
Time frame: 29 months
circumference gain(cm/week)
Time frame: 29 months
10 secondary outcomes
days of postnatal life when reaching full enteral nutrion(d)
Time frame: 29 months
proportion of breast milk feeding(%)
Time frame: 29 months
days of postnatal life with the lowst weight during hospitalisation(d)
Time frame: 29 months
the lowest weight during hospitalisation(g)
Time frame: 29 months
days of postnatal life that regain birth weight(d)
Time frame: 29 months
incidence of hyperglycemia(%)
Time frame: 29 months
incidence of hypoglycemia(%)
Time frame: 29 months
incidence of hypebilirubinemia(%)
Time frame: 29 months
incidence of neonatal infection(%)
Time frame: 29 months
incidence of neonatal anemia(%)
Time frame: 29 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing new systemic nutrition management protocol in people with Late Premature Infants and Systemic Nutritional Management, run by Peking Union Medical College Hospital.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
days of postnatal life when enteral nutrition reaching 120kcal/kg/d (time frame: 29 months). The study lists 4 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 1 Jan 2016.