Nutritional Care and Head Growth in Preterm Infants

NCT ID: NCT03635944

Last Updated: 2018-08-17

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

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-07-01

Brief Summary

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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.

Detailed Description

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In a retrospective study, all ELBW infants (birth weight under 1000 g) with a gestational age between 23 and 28 weeks were included if they were admitted during the first 24 hours of life and stayed for at least seven weeks in two European units (Lyon, france, and Stockholm, Sweden). Parenteral and enteral nutrition policies were detailed and protein and energy intakes were collected.Growth assessment Postnatal growth was precisely evaluated and compared in the two groups of infants.

Body weight, crown-heel length and head circumference were measured in both units at birth and until discharge. We calculated z-scores and changes in z-scores between birth and 36 weeks post-conceptional age (delta z-score) for body weight, HC, and crown-to-heel length using Olsen's references. Intra-uterine growth restriction was defined as a birth weight below or equal to minus two standard deviations. Extra-uterine growth restriction was defined as a z-score loss above or equal one standard deviation between birth and 36 weeks PCA. I

Conditions

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Prematurity; Extreme Growth Retardation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group A

Infants born in Lyon (France)

No interventions assigned to this group

Group B

Infants born in Stockholm (Sweden)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Neonates with congenital anomalies
Minimum Eligible Age

1 Minute

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital de la Croix-Rousse

OTHER

Sponsor Role lead

Responsible Party

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Jean-charles PICAUD, MD, PhD

professor of pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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jean-charles picaud, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital de la croix rousse

Locations

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Hopital de la croix rousse

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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PICAUD JC

Identifier Type: -

Identifier Source: org_study_id

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