underdeveloped left ventricular structures in human fetus MedDRA version: 20.0 Level: PT Classification code 10021076 Term: Hypoplastic left heart syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Product Name: O2, gas for medical purposes
Pharmaceutical Form:
INN or Proposed INN: OXYGEN
Other descriptive name: oxygen, medical gas
Concentration unit: l litre(s)
Concentration type: equal
Concen
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: mother: - >= 18 years of age - third trimester of pregnancy - non-smoker - A. uterina doppler ultrasound at least one-sided without pathological findings Fetus: - cardiac disorder with at least one underdeveloped left ventricular structure detected by echocardiography - sufficient fetal cardiac function Are the trial subjects under 18? yes Number of subjects for this age range: 64 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Mother: - alcohol or drug abuse - multiple pregnancy - adipositas permagna (BMI>40) - diabetes melllitus, insulin-dependent - obstetrical issues (e.g. Cervix uteri <25mm, premature contractions, preeclampsia, eclampsia, HELLP Syndrome, …) - fetus impossible to evaluate by echocardiography - patholog. utero-placental resistance - cardiac failure (NYHA III/IV or decompensated) - severe COPD, hypercapnia Fetus: - underlying disease or chromosomal abnormality which might influence the effect of MFHO - hemodynamic factors with influence on filling/emptying of the left heart which might affect MFHO efficacy - fetal cardiac failure - Hydrops fetalis - severe growth retardation - no flow in A. umbilicalis - severe extracardiac malformations - visit 2: inadequate response to O2 provocation during echocardiography
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evidence of efficacy of materno-fetal hyperoxygenation (MFHO) during the third trimester of pregnancy on growth of underdeveloped fetal left ventricular structures;Secondary Objective: Evaluation of - safety of MFHO during late pregnancy for mother/child - Impact of MFHO during late pregnancy on infant development post partum - Impact of MFHO during late pregnancy on fetal brain development - Impact of MFHO during late pregnancy on infant brain development - Impact of MFHO during late pregnancy on nature and frequency of cardiac surgery and catheter interventions in infants ;Primary end point(s): median change of the sum of the Z-scores of the initially chosen echocardiographic fetal heart structures under O2 provocation at the time point PW35d0 (+/- 2 days) compared to the initial values on PW32d0 (+/- 2 days) under O2 provocation.;Timepoint(s) of evaluation of this end point: PW35d0 (+/- 2 days) compared to PW32d0 (+/- 2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - number of maternal AE and SAE - number of fetal /newborn AE and SAE - number of maternal AR and SAR - number of fetal /newborn AR and SAR - neurological development of the child - head growth intrauterine and postnatal - option of biventricular correction of the cardiac defect (y/n) - univentricular palliation necessary (y/n) - aortic coarctation requiring treatment (y/n) - nature and number of postnatal cardiosurgical interventions - nature and number of postnatal catheter interventions - occurence of retinopathy - occurence or periventricular leucomalacia;Timepoint(s) of evaluation of this end point: AE/SAE: from visit 2 until visit 7 all others: from visit 2 until visit 10 (EOS) | — |
Countries
Germany
Contacts
Public ContactKinder- und Jugendklinik
Universitätsklinikum Erlangen
Outcome results
None listed