Supply With Micronutrients (Purine and Pyrimidine) in Infants: a Prospective and Observational Study
- Conditions
- Prematurity
- Interventions
- Procedure: cord bloodProcedure: blood sample infantProcedure: blood sample motherProcedure: breast milk
- Registration Number
- NCT03532633
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
Concentrations of micronutrients (especially purine and pyrimidine) in cord blood, blood of mothers and infants and human milk is studied
- Detailed Description
Collection of:
1. cord plasma in preterm and term infants.
2. remnants of clinically indicated blood samples of mothers 24 hours before or after birth.
3. remnants of clinically indicated blood samples of preterm and term infants during neonatal care.
4. breast milk once a weak during neonatal care of the infant.
Determination concentrations of micronutrients by mass spectrometry.
Aim is to compare cord plasma concentrations with postnatal plasma concentrations and to measure concentrations in breast milk to determine the actual supply.
Update September 2020:
The results obtained according to the original protocol revealed a serious sample instability when using remnants of clinical blood samples. Remnants can not be used and therefore the protocol had to be changed. A new approval of the Ethics Committee was obtained and is available to the study team. The following changes for sample collection were implemented: an additional blood sample (2.7ml EDTA blood) is taken from the mothers after approval.The blood samples of premature and newborns (max. 3x 0.2 ml) are obtained when a clinically indicated blood sample is taken. In both cases the serum is frozen immediately within one hour after collection.
Due to these changes, the expected end of the study is postponed to 2021.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 23+0-42+6 SSW
- congenital malformation, genetic disorders
- metabolic disease of the infant
- missing agreement
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 28-31w blood sample mother preterm infants 28+0-31+6SSW 32-34w cord blood preterm infants 32+0 - 34+6SSW 37-42w blood sample infant term infants 37+0-42+6 23-27w breast milk preterm infants 23+0-27+6SSW 32-34w blood sample infant preterm infants 32+0 - 34+6SSW 35-36w blood sample infant preterm infants 35+0-36+6 SSW 23-27w blood sample infant preterm infants 23+0-27+6SSW 28-31w cord blood preterm infants 28+0-31+6SSW 28-31w blood sample infant preterm infants 28+0-31+6SSW 28-31w breast milk preterm infants 28+0-31+6SSW 35-36w cord blood preterm infants 35+0-36+6 SSW 23-27w cord blood preterm infants 23+0-27+6SSW 35-36w blood sample mother preterm infants 35+0-36+6 SSW 37-42w blood sample mother term infants 37+0-42+6 23-27w blood sample mother preterm infants 23+0-27+6SSW 35-36w breast milk preterm infants 35+0-36+6 SSW 32-34w blood sample mother preterm infants 32+0 - 34+6SSW 32-34w breast milk preterm infants 32+0 - 34+6SSW 37-42w cord blood term infants 37+0-42+6 37-42w breast milk term infants 37+0-42+6
- Primary Outcome Measures
Name Time Method Concentration of purine and pyrimidine in cord plasma at birth
- Secondary Outcome Measures
Name Time Method Concentration of purine and pyrimidine in neonatal 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) Concentration of purine and pyrimidine in breast milk once a week before discharge home from the initial neonatal hospitalization, maximum 8 weeks Concentration of purine and pyrimidine in plasma of mothers 24 hours before and after birth
Trial Locations
- Locations (1)
University Children's Hospital Tuebingen
🇩🇪Tuebingen, Germany