Skip to content

The NeoLifes MICKEY MOUSE trial: MICrobiota, KEY between Mother and Off-spring USsing SEquencing techniques.

The NeoLifes MICKEY MOUSE trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28522
Enrollment
150
Registered
2021-04-19
Start date
2021-05-03
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

necrotizing enterocolitis

Interventions

n.a.

Sponsors

n.a.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children admitted to the neonatology department, which are - born at a gestational age of = 30 weeks - and/or born with a birth weight of = 1000 gram, and parent consent in participating in the study.

Exclusion criteria

Exclusion criteria: Abdominal disease such as abdominal wall defects, congenital intestinal atresia, as well as major congenital heart defects (e.g. Tetrology of Fallot).

Design outcomes

Primary

MeasureTime frame
Development of necrotizing enterocolitis

Secondary

MeasureTime frame
Neonatal: faecal microbiota, faecal human DNA methylation pattern (shedded enterocytes and lymphocytes), faecal bile salts acids, faecal SCFA and iAP, iAP expression in the margins of the resection specimens, urine metabolome, cerebral and intestinal tissue oxygen saturation (as measured with NIRS), peak systolic flow velocity and the mean end-diastolic flow velocity of the superior mesenteric artery and a branch of the medial cerebral artery assessment using Echo Doppler, serum IMA, serum (i)AP, T1/T2 cytokine ratio in umbilical cord blood, iAP in surgical resection material. Mother: microbiota in mother's milk, placenta and rectal microbiota; amniotic fluid in case of caesarean, validated diet questionnaire ('Wat een Nederland' questionnaire as used by RIVM)

Contacts

Public ContactDaphne Klerk

University Medical Center Groningen

d.h.klerk@umcg.nl0629384154

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)