Clinical trial NCT02605577: Research of Systemic Management for Late Preterm Infants Nutrition in China
Official title: Research of Systemic Management for Late Preterm Infants Nutrition in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Late Premature Infants
Systemic Nutritional Management
Keywords: late preterm infants
nutrition
systemic management
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Peking University People's Hospital
name: Peking University Third Hospital
name: Beijing Children's Hospital
name: Capital Institute of Pediatrics, China
name: Beijing Obstetrics and Gynecology Hospital
name: Beijing Huaxin Hospital
name: Beijing Friendship Hospital
name: Beijing Ditan Hospital
name: Bayi Children's Hospital Affiliated to Beijing Military Gen Hospital
name: Beijing Shangdi Hospital
name: Beijing Tongzhou District Maternal and Child Health Hospital
name: Beijing Yanqing County Hospital
name: People's Hospital of Beijing Daxing District
name: Beijing Hospital
name: Civil Aviation General Hospital
name: Beijing Anzhen Hospital
name: Military 301 Hospital
name: Beijing Haidian Maternal and Child Health Hospital
name: Beijing 302 Hospital
name: Beijing Chaoyang District Maternal and Child Health Hospital
name: China-Japan Friendship Hospital
name: Military 306 Hospital
name: Beijing Chao Yang Hospital
name: Navy General Hospital, Beijing
First posted: 2015-11-16
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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)

Primary outcomes:
measure: days of postnatal life when enteral nutrition reaching 120kcal/kg/d
timeFrame: 29 months
measure: weight gain(g/kg/week)
timeFrame: 29 months
measure: length gain(cm/week)
timeFrame: 29 months
measure: circumference gain(cm/week)
timeFrame: 29 months
Secondary outcomes:
measure: days of postnatal life when reaching full enteral nutrion(d)
timeFrame: 29 months
measure: proportion of breast milk feeding(%)
timeFrame: 29 months
measure: days of postnatal life with the lowst weight during hospitalisation(d)
timeFrame: 29 months
measure: the lowest weight during hospitalisation(g)
timeFrame: 29 months
measure: days of postnatal life that regain birth weight(d)
timeFrame: 29 months
measure: incidence of hyperglycemia(%)
timeFrame: 29 months
measure: incidence of hypoglycemia(%)
timeFrame: 29 months
measure: incidence of hypebilirubinemia(%)
timeFrame: 29 months
measure: incidence of neonatal infection(%)
timeFrame: 29 months
measure: incidence of neonatal anemia(%)
timeFrame: 29 months
Other outcomes:
Locations:
Study officials:
References: