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Research of Systemic Management for Late Preterm Infants Nutrition in China (NLP)

Primary Purpose

Late Premature Infants, Systemic Nutritional Management

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
new systemic nutrition management protocol
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Late Premature Infants focused on measuring late preterm infants, nutrition, systemic management

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • preterm infants with gestational age 34 weeks to 36 weeks and 6 days

Exclusion Criteria:

  • 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    experimental group

    control group

    Arm Description

    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" )

    group of late preterm infants using current nutritional management protocol during hospital stay

    Outcomes

    Primary Outcome Measures

    days of postnatal life when enteral nutrition reaching 120kcal/kg/d
    weight gain(g/kg/week)
    length gain(cm/week)
    circumference gain(cm/week)

    Secondary Outcome Measures

    days of postnatal life when reaching full enteral nutrion(d)
    the incidence of complications of preterm infants
    proportion of breast milk feeding(%)
    days of postnatal life with the lowst weight during hospitalisation(d)
    the lowest weight during hospitalisation(g)
    days of postnatal life that regain birth weight(d)
    incidence of hyperglycemia(%)
    incidence of hypoglycemia(%)
    incidence of hypebilirubinemia(%)
    incidence of neonatal infection(%)
    incidence of neonatal anemia(%)

    Full Information

    First Posted
    October 6, 2015
    Last Updated
    December 30, 2015
    Sponsor
    Peking Union Medical College Hospital
    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, Military 301 Hospital, Beijing Haidian Maternal and Child Health Hospital, Beijing 302 Hospital, Beijing Chaoyang District Maternal and Child Health Hospital, China-Japan Friendship Hospital, Military 306 Hospital, Beijing Chao Yang Hospital, Navy General Hospital, Beijing
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02605577
    Brief Title
    Research of Systemic Management for Late Preterm Infants Nutrition in China
    Acronym
    NLP
    Official Title
    Research of Systemic Management for Late Preterm Infants Nutrition in China
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    September 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking Union Medical College Hospital
    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, Military 301 Hospital, Beijing Haidian Maternal and Child Health Hospital, Beijing 302 Hospital, Beijing Chaoyang District Maternal and Child Health Hospital, China-Japan Friendship Hospital, Military 306 Hospital, Beijing Chao Yang Hospital, Navy General Hospital, Beijing

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Late Premature Infants, Systemic Nutritional Management
    Keywords
    late preterm infants, nutrition, systemic management

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    2000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    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" )
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    group of late preterm infants using current nutritional management protocol during hospital stay
    Intervention Type
    Procedure
    Intervention Name(s)
    new systemic nutrition management protocol
    Intervention Description
    a new established systemic nutrition management protocol
    Primary Outcome Measure Information:
    Title
    days of postnatal life when enteral nutrition reaching 120kcal/kg/d
    Time Frame
    29 months
    Title
    weight gain(g/kg/week)
    Time Frame
    29 months
    Title
    length gain(cm/week)
    Time Frame
    29 months
    Title
    circumference gain(cm/week)
    Time Frame
    29 months
    Secondary Outcome Measure Information:
    Title
    days of postnatal life when reaching full enteral nutrion(d)
    Description
    the incidence of complications of preterm infants
    Time Frame
    29 months
    Title
    proportion of breast milk feeding(%)
    Time Frame
    29 months
    Title
    days of postnatal life with the lowst weight during hospitalisation(d)
    Time Frame
    29 months
    Title
    the lowest weight during hospitalisation(g)
    Time Frame
    29 months
    Title
    days of postnatal life that regain birth weight(d)
    Time Frame
    29 months
    Title
    incidence of hyperglycemia(%)
    Time Frame
    29 months
    Title
    incidence of hypoglycemia(%)
    Time Frame
    29 months
    Title
    incidence of hypebilirubinemia(%)
    Time Frame
    29 months
    Title
    incidence of neonatal infection(%)
    Time Frame
    29 months
    Title
    incidence of neonatal anemia(%)
    Time Frame
    29 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: preterm infants with gestational age 34 weeks to 36 weeks and 6 days Exclusion Criteria: 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)

    12. IPD Sharing Statement

    Learn more about this trial

    Research of Systemic Management for Late Preterm Infants Nutrition in China

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