Supply With Micronutrients (Purine and Pyrimidine) in Infants: a Prospective and Observational Study

University Hospital Tuebingen

Status: Unknown

Conditions: Prematurity

Treatments: Procedure: blood sample mother; Procedure: breast milk; Procedure: cord blood; Procedure: blood sample infant

Study type: Observational

Funder types: Other

Identifiers

NCT03532633

NEO-MICRO

Details and patient eligibility

About

Concentrations of micronutrients (especially purine and pyrimidine) in cord blood, blood of mothers and infants and human milk is studied

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 23+0-42+6 SSW

Exclusion criteria

• congenital malformation, genetic disorders
• metabolic disease of the infant
• missing agreement

Trial design

150 participants in 5 patient groups

23-27w

Description:

preterm infants 23+0-27+6SSW

Treatment:

Procedure: blood sample mother

Procedure: breast milk

Procedure: cord blood

Procedure: blood sample infant

28-31w

Description:

preterm infants 28+0-31+6SSW

Treatment:

Procedure: blood sample mother

Procedure: breast milk

Procedure: cord blood

Procedure: blood sample infant

32-34w

Description:

preterm infants 32+0 - 34+6SSW

Treatment:

Procedure: blood sample mother

Procedure: breast milk

Procedure: cord blood

Procedure: blood sample infant

35-36w

Description:

preterm infants 35+0-36+6 SSW

Treatment:

Procedure: blood sample mother

Procedure: breast milk

Procedure: cord blood

Procedure: blood sample infant

37-42w

Description:

term infants 37+0-42+6

Treatment:

Procedure: blood sample mother

Procedure: breast milk

Procedure: cord blood

Procedure: blood sample infant