PrematurityNCT03532633
Supply With Micronutrients (Purine and Pyrimidine) in Infants: a Prospective and Observational Study
An observational study of Prematurity, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Concentrations of micronutrients (especially purine and pyrimidine) in cord blood, blood of mothers and infants and human milk is studied Read more about this study
- Who is it for?
- Ages 0 minutes to 6 months
- Conditions the study is for
- Prematurity
- What is being tested?
- cord blood, blood sample infant and blood sample mother
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2017to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 minutes to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: infants and preterm infants
Who may be able to join
- 23+0-42+6 SSW
Who cannot join
- congenital malformation, genetic disorders
- metabolic disease of the infant
- missing agreement
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Children's Hospital Tuebingen
Tübingen, 72076
Axel Franz, MD, +497071290, axel.franz@med.uni-tuebingen.de
Axel Franz, MD
About this study
Official title: Beobachtungsstudie Zur Versorgung Reif- Und Frühgeborener Mit ausgewählten Mikronährstoffen Wissenschaftliche Untersuchung Bei Minderjährigen
Concentrations of micronutrients (especially purine and pyrimidine) in cord blood, blood of mothers and infants and human milk is studied
Read the detailed description
Collection of:
- cord plasma in preterm and term infants.
- remnants of clinically indicated blood samples of mothers 24 hours before or after birth.
- remnants of clinically indicated blood samples of preterm and term infants during neonatal care.
- 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.
- Conditions
- Prematurity
- Being tested
- cord blood, blood sample infant, blood sample mother, breast milk
- Keywords
- infant, cord, micronutrients, purine, pyrimidine
- Medical subject headings
- Premature Birth, Cone-Rod Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cord bloodProcedure or surgery
collection of cord blood
blood sample infantProcedure or surgery
collection of remnant of clinically indicated blood sample
blood sample motherProcedure or surgery
collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed
breast milkProcedure or surgery
collection of breast milk 1/week during neonatal care (maximum 8 weaks)
| Study group | Role | What they receive |
|---|---|---|
| 23-27w | preterm infants 23+0-27+6SSW Receives: Procedure: cord blood; Procedure: blood sample infant; Procedure: blood sample mother; Procedure: breast milk | |
| 28-31w | preterm infants 28+0-31+6SSW Receives: Procedure: cord blood; Procedure: blood sample infant; Procedure: blood sample mother; Procedure: breast milk | |
| 32-34w | preterm infants 32+0 - 34+6SSW Receives: Procedure: cord blood; Procedure: blood sample infant; Procedure: blood sample mother; Procedure: breast milk | |
| 35-36w | preterm infants 35+0-36+6 SSW Receives: Procedure: cord blood; Procedure: blood sample infant; Procedure: blood sample mother; Procedure: breast milk | |
| 37-42w | term infants 37+0-42+6 Receives: Procedure: cord blood; Procedure: blood sample infant; Procedure: blood sample mother; Procedure: breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of purine and pyrimidine in cord plasma
Measured: at birth
Secondary outcomes (3)
Concentration of purine and pyrimidine in neonatal plasma
Measured: 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
Measured: once a week before discharge home from the initial neonatal hospitalization, maximum 8 weeks
Concentration of purine and pyrimidine in plasma of mothers
Measured: 24 hours before and after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start1 Mar 2017
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Axel Franz, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532633
- Sponsor's protocol ID
- NEO-MICRO
- Status last verified
- Sep 2020
- First submitted
- 9 May 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beobachtungsstudie Zur Versorgung Reif- Und Frühgeborener Mit ausgewählten Mikronährstoffen Wissenschaftliche Untersuchung Bei Minderjährigen
- ClinicalTrials.gov ID
- NCT03532633
- Acronym / sponsor ID
- NEO-MICRO
- Conditions
- Prematurity
- Keywords
- infant, cord, micronutrients, purine, pyrimidine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Concentrations of micronutrients (especially purine and pyrimidine) in cord blood, blood of mothers and infants and human milk is studied
Detailed description
Collection of:
- cord plasma in preterm and term infants.
- remnants of clinically indicated blood samples of mothers 24 hours before or after birth.
- remnants of clinically indicated blood samples of preterm and term infants during neonatal care.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 23-27w | – | Procedure: cord blood, Procedure: blood sample infant, Procedure: blood sample mother, Procedure: breast milkpreterm infants 23+0-27+6SSW |
| 28-31w | – | Procedure: cord blood, Procedure: blood sample infant, Procedure: blood sample mother, Procedure: breast milkpreterm infants 28+0-31+6SSW |
| 32-34w | – | Procedure: cord blood, Procedure: blood sample infant, Procedure: blood sample mother, Procedure: breast milkpreterm infants 32+0 - 34+6SSW |
| 35-36w | – | Procedure: cord blood, Procedure: blood sample infant, Procedure: blood sample mother, Procedure: breast milkpreterm infants 35+0-36+6 SSW |
| 37-42w | – | Procedure: cord blood, Procedure: blood sample infant, Procedure: blood sample mother, Procedure: breast milkterm infants 37+0-42+6 |
Who may qualify
- Ages
- 0 minutes to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants and preterm infants
Key inclusion criteria (1 listed)
- 23+0-42+6 SSW
Key exclusion criteria (3 listed)
- congenital malformation, genetic disorders
- metabolic disease of the infant
- missing agreement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cord bloodcollection of cord blood | Procedure or surgery | 23-27w, 28-31w, 32-34w, 35-36w, 37-42w |
| blood sample infantcollection of remnant of clinically indicated blood sample | Procedure or surgery | 23-27w, 28-31w, 32-34w, 35-36w, 37-42w |
| blood sample mothercollection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed | Procedure or surgery | 23-27w, 28-31w, 32-34w, 35-36w, 37-42w |
| breast milkcollection of breast milk 1/week during neonatal care (maximum 8 weaks) | Procedure or surgery | 23-27w, 28-31w, 32-34w, 35-36w, 37-42w |
Primary outcome
Concentration of purine and pyrimidine in cord plasma
Time frame: at birth
3 secondary outcomes
Concentration of purine and pyrimidine in neonatal plasma
Time frame: 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
Time frame: once a week before discharge home from the initial neonatal hospitalization, maximum 8 weeks
Concentration of purine and pyrimidine in plasma of mothers
Time frame: 24 hours before and after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Franz principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrin Böckmann (+49707129 ext. 82621, katrin.a.boeckmann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of purine and pyrimidine in cord plasma (time frame: at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.