NCT03635944

Brief Summary

As extremely low birth weight infants are high-risk patients, the study aimed to compare neonatal care, nutritional strategy and postnatal growth of these infants in two European neonatal units. A retrospective study included extremely low birth weight infants born in Lyon, France or in Stockholm, Sweden. Data on morbidity, treatments, care practices, macro-nutrient intakes and postnatal growth were collected to determine risk factors of extra uterine growth restriction at discharge. By comparing postnatal growth in ELBW infants hospitalized in two European neonatal intensive care units with different nutritional and extra nutritional care,our objective was to evaluate the role of nutrition in this population of preterm infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

August 14, 2018

Last Update Submit

August 15, 2018

Conditions

Keywords

growthsmall for gestational ageprematuritybreastfeedingfortificationparenteral nutritionnutrition

Outcome Measures

Primary Outcomes (1)

  • Weight gain during hospitalization

    difference in weight between birth and discharge

    between birth and 40 weeks

Secondary Outcomes (2)

  • Crown-heel length gain during hospitalization

    between birth and 40 weeks

  • Head circumference gain during hospitalization

    between birth and 40 weeks

Study Arms (2)

Group A

Infants born in Lyon (France)

Group B

Infants born in Stockholm (Sweden)

Eligibility Criteria

Age1 Minute - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Extremely low birth weight infants born in two European tertiary care centres: neonatal unit of Croix Rousse Hospital in Lyon, France and the neonatal unit of Astrid Lindgren Children's Hospital in Stockholm, Sweden

You may qualify if:

  • birth weight under 1000 grams
  • gestational age (GA) between 23 and 28 weeks
  • born in 2012
  • admitted during the first 24 hours of life
  • stayed in one of the two studied units for at least 7 weeks before transfer to the referring hospital, discharge to home or death.

You may not qualify if:

  • Neonates with congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital de la croix rousse

Lyon, 69004, France

Location

MeSH Terms

Conditions

Premature BirthBreast FeedingHyperphagia

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • jean-charles picaud, MD, PhD

    Hopital de la croix rousse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of pediatrics

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 17, 2018

Study Start

December 1, 2016

Primary Completion

May 1, 2017

Study Completion

July 1, 2018

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations