Observational Study of Choline, Its Metabolites, and Phospholipids in Preterm Infants

Study Overview
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Brief Summary
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To study concentrations of choline, its metabolites, and phospholipids in cord blood and remnants of clinically indicated blood samples

Detailed Description
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To collect cord plasma in preterm and term infants. To collect remnants of clinically indicated blood samples in parturients and hospitalized preterm infants during neonatal intensive care. To determine concentrations of choline, its metabolites, and phospholipids by mass spectrometry. To compare cord plasma concentrations with postnatal plasma concentrations.

Official Title
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Supply of Term and Preterm Neonates With Choline, Lipids and Vitamines

Conditions
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Prematurity

Intervention / Treatment
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* Other: collection of remnant of clinically indicated blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: meeting criteria of the 4 cohorts Exclusion Criteria: none pre-defined

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| parturient<br>mother who had given birth within 48 hours of clinically indicated blood sampling | Other: collection of remnant of clinically indicated blood sample<br>* collection of remnant of clinically indicated blood sample<br>|
| healthy, non-pregnant, female volunteers<br>healthy, non-pregnant, female volunteers | Other: collection of remnant of clinically indicated blood sample<br>* collection of remnant of clinically indicated blood sample<br>|
| preterm infant<br>gestational age at birth < 37 weeks | Other: collection of remnant of clinically indicated blood sample<br>* collection of remnant of clinically indicated blood sample<br>|
| term infant<br>gestational age at birth >36 weeks | Other: collection of remnant of clinically indicated blood sample<br>* collection of remnant of clinically indicated blood sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of choline in plasma |  | at times when a clinically indicated blood sample is taken before discharge home from the initial neonatal hospitalization (at a postnatal age of up to 4-5 months at the most in very preterm infants) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentrations of choline metabolites |  | at times when a clinically indicated blood sample is taken before discharge home from the initial neonatal hospitalization (at a postnatal age of up to 4-5 months at the most in very preterm infants) | 
| Concentrations of molecular species of phosphatidylcholine and phosphatidylethanolamine |  | at times when a clinically indicated blood sample is taken before discharge home from the initial neonatal hospitalization (at a postnatal age of up to 4-5 months at the most in very preterm infants) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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choline, infant, premature, infant, newborn