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Development of small blood vessels in the kidneys of preterm infants

Ex utero Development of Intra-renal Vasculature in Preterm Infants from 24 weeks gestation to Term Equivalent Age

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001387819
Acronym
DIVALI
Enrollment
25
Registered
2021-10-14
Start date
2021-10-23
Completion date
2023-10-14
Last updated
2022-10-03

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

Conditions

None listed

Brief summary

This study will characterize the development of the small blood vessels in the outermost layer of the kidney after very preterm birth (as early as 24 of 40 weeks of pregnancy) to term and to one year of age, using a new ultrasound mode with the ability to demonstrate blood flow in very small blood vessels (SMI ultrasound). The study will also compare the findings of the blood vessel development with measurements traditionally used to measure the function of the kidneys.

Interventions

Exposure: preterm birth in 4 brackets of gestational age: 24 weeks, 28 weeks, 32 weeks, 36 weeks Observations: Vascularity of kidney cortex (the study involves study participants to undergo Doppler ultrasound of kidney cortex) Observation period: From birth to 12 months corrected age

Sponsors

Dr Eveline Staub
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
0 to 72 Hours
Healthy volunteers
No

Inclusion criteria

Preterm infant born in one of the 4 gestational age groups: Group 1: 24 gestational weeks Group 2: 28 gestational weeks Group 3: 32 gestational weeks Group 4: 36 gestational weeks Group 5 (control group): 39-40 gestational weeks

Exclusion criteria

- Antenatally detected congenital abnormality of the kidneys or urinary tract, including: o Underdevelopment or absence of one or both kidney o Horseshoe kidney or fused kidneys o One or more intrarenal cysts o Duplex kidney or duplicated collecting system o Hydronephrosis, ureteropelvic junction obstruction, megaureter o Posterior urethral valves o Any abnormality of the kidney or urogenital system or associated condition with the potential to affect the normal renal development - If one of the above conditions are not known at the time of enrolment, but diagnosed with the first assessment at less than 72 hours after birth, the infant will be excluded from the study and referred for specialist assessment and management. - Moribund infant who is not expected to survive beyond the first scheduled study assessment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026