Research of Systemic Management for Late Preterm Infants Nutrition in China

NCT ID: NCT02605577

Last Updated: 2016-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Late Premature Infants Systemic Nutritional Management

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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" )

Group Type EXPERIMENTAL

new systemic nutrition management protocol

Intervention Type PROCEDURE

a new established systemic nutrition management protocol

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

new systemic nutrition management protocol

a new established systemic nutrition management protocol

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking University First Hospital

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role collaborator

Beijing Children's Hospital

OTHER

Sponsor Role collaborator

Capital Institute of Pediatrics, China

OTHER

Sponsor Role collaborator

Beijing Obstetrics and Gynecology Hospital

OTHER

Sponsor Role collaborator

Beijing Huaxin Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Beijing Ditan Hospital

OTHER

Sponsor Role collaborator

Bayi Children's Hospital Affiliated to Beijing Military Gen Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Shangdi Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Tongzhou District Maternal and Child Health Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Yanqing County Hospital

UNKNOWN

Sponsor Role collaborator

People's Hospital of Beijing Daxing District

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Civil Aviation General Hospital

OTHER

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Military 301 Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Haidian Maternal and Child Health Hospital

OTHER

Sponsor Role collaborator

Beijing 302 Hospital

OTHER

Sponsor Role collaborator

Beijing Chaoyang District Maternal and Child Health Hospital

UNKNOWN

Sponsor Role collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Military 306 Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Navy General Hospital, Beijing

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Li zhenghong

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SMFLPIN

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.