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

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ClinicalTrials.gov Identifier: NCT02605577
Recruitment Status : Unknown
Verified December 2015 by Li zhenghong, Peking Union Medical College Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : November 16, 2015
Last Update Posted : January 1, 2016
Sponsor:
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 PLA Army General Hospital, China
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 Gen Hospital
Beijing Anzhen Hospital
Military 301 Hospital
Beijing Haidian District 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
Aviation General Hospital
Information provided by (Responsible Party):
Li zhenghong, Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Late Premature Infants Systemic Nutritional Management Procedure: new systemic nutrition management protocol Not Applicable

Detailed Description:

The research content of the project includes three parts:

  1. Investigation on nutritional status of late preterm infants.
  2. Setting up systemic nutritional management of late preterm infants
  3. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Research of Systemic Management for Late Preterm Infants Nutrition in China
Study Start Date : January 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental group
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" )
Procedure: new systemic nutrition management protocol
a new established systemic nutrition management protocol

No Intervention: control group
group of late preterm infants using current nutritional management protocol during hospital stay



Primary Outcome Measures :
  1. days of postnatal life when enteral nutrition reaching 120kcal/kg/d [ Time Frame: 29 months ]
  2. weight gain(g/kg/week) [ Time Frame: 29 months ]
  3. length gain(cm/week) [ Time Frame: 29 months ]
  4. circumference gain(cm/week) [ Time Frame: 29 months ]

Secondary Outcome Measures :
  1. days of postnatal life when reaching full enteral nutrion(d) [ Time Frame: 29 months ]
    the incidence of complications of preterm infants

  2. proportion of breast milk feeding(%) [ Time Frame: 29 months ]
  3. days of postnatal life with the lowst weight during hospitalisation(d) [ Time Frame: 29 months ]
  4. the lowest weight during hospitalisation(g) [ Time Frame: 29 months ]
  5. days of postnatal life that regain birth weight(d) [ Time Frame: 29 months ]
  6. incidence of hyperglycemia(%) [ Time Frame: 29 months ]
  7. incidence of hypoglycemia(%) [ Time Frame: 29 months ]
  8. incidence of hypebilirubinemia(%) [ Time Frame: 29 months ]
  9. incidence of neonatal infection(%) [ Time Frame: 29 months ]
  10. incidence of neonatal anemia(%) [ Time Frame: 29 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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Responsible Party: Li zhenghong, associate professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02605577     History of Changes
Other Study ID Numbers: SMFLPIN
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015

Keywords provided by Li zhenghong, Peking Union Medical College Hospital:
late preterm infants
nutrition
systemic management