Nutritional Care and Head Growth in Preterm Infants (KARLY)

H

Hôpital de la Croix-Rousse

Status

Completed

Conditions

Growth Retardation
Prematurity; Extreme

Study type

Observational

Funder types

Other

Identifiers

NCT03635944
PICAUD JC

Details and patient eligibility

About

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.

Full description

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

Enrollment

71 patients

Sex

All

Ages

1 minute to 6 months old

Volunteers

No Healthy Volunteers

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

Trial design

71 participants in 2 patient groups

Group A
Description:
Infants born in Lyon (France)
Group B
Description:
Infants born in Stockholm (Sweden)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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