Nutritional Care and Head Growth in Preterm Infants (KARLY)

Nutritional Care Influences Head Growth at Discharge in Extremely Low Birth Weight Infants.

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.

Study Overview

• Status: Completed
• Conditions: Growth Retardation; Prematurity; Extreme

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hopital de la croix rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 6 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group A; Infants born in Lyon (France)
Group B; Infants born in Stockholm (Sweden)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight gain during hospitalization	difference in weight between birth and discharge	between birth and 40 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crown-heel length gain during hospitalization	difference in recumbent length between birth and discharge	between birth and 40 weeks
Head circumference gain during hospitalization	difference in head circumference between birth and discharge	between birth and 40 weeks

Collaborators and Investigators

• Sponsor: Hôpital de la Croix-Rousse

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: nutrition; growth; breastfeeding; prematurity; parenteral nutrition; fortification; small for gestational age
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: PICAUD JC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No