NCT02605577

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

2.7 years

First QC Date

October 6, 2015

Last Update Submit

December 30, 2015

Conditions

Late Premature InfantsSystemic Nutritional Management

Keywords

late preterm infantsnutritionsystemic management

Outcome Measures

Primary Outcomes (4)

  • days of postnatal life when enteral nutrition reaching 120kcal/kg/d

    29 months

  • weight gain(g/kg/week)

    29 months

  • length gain(cm/week)

    29 months

  • circumference gain(cm/week)

    29 months

Secondary Outcomes (10)

  • days of postnatal life when reaching full enteral nutrion(d)

    29 months

  • proportion of breast milk feeding(%)

    29 months

  • days of postnatal life with the lowst weight during hospitalisation(d)

    29 months

  • the lowest weight during hospitalisation(g)

    29 months

  • days of postnatal life that regain birth weight(d)

    29 months

  • +5 more secondary outcomes

Study Arms (2)

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" )

Procedure: new systemic nutrition management protocol

control group

NO INTERVENTION

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

Interventions

new systemic nutrition management protocolPROCEDURE

a new established systemic nutrition management protocol

experimental group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

October 6, 2015

First Posted

November 16, 2015

Study Start

January 1, 2016

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

January 1, 2016

Record last verified: 2015-12