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Establishing Reference Intervals for Early Ultrasonographic Hemodynamic Indices in Healthy Neonates from Multi-Altitude Regions of China

Establishing Reference Intervals for Early Ultrasonographic Hemodynamic Indices in Healthy Neonates from Multi-Altitude Regions of China

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119544
Enrollment
Unknown
Registered
2026-02-28
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Hemodynamics of cardiac and cerebral in healthy neonates

Interventions

Heathy neonates:None

Sponsors

Chengdu Women's and Children's Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. The mother lived continuously in the same altitude region for more than 3 months during pregnancy; 2. The newborn is a singleton appropriate-for-gestational-age (AGA) neonate with a gestational age between 35+0 and 41+6 weeks; 3. Informed consent is obtained from the legal guardian.

Exclusion criteria

Exclusion criteria: Meeting any of the following criteria: 1. The legal guardian requests withdrawal from the study, or the newborn is admitted to the neonatal department for any reason within 96 hours after birth, or is discharged from the hospital against medical advice following the mother; 2. Other factors that may affect the postnatal transition period: (1) Any of the following maternal conditions during pregnancy: pre-existing diabetes/gestational diabetes, pre-existing hypertension/gestational hypertension, intrahepatic cholestasis of pregnancy, intra-amniotic infection, thyroid dysfunction complications, heart disease, connective tissue disease, prenatal diagnosis of placental dysfunction indicated by absent or reversed end-diastolic flow in the umbilical artery on fetal Doppler ultrasound, or use of prenatal antidepressant medication; (2)Any neonatal conditions (perinatal hypoxia with umbilical cord blood pH < 7.0 or Apgar score at 5 minutes < 5, or requiring resuscitation, or admission to the neonatal department, or any clinically suspected congenital anomaly); 3. Congenital heart disease detected on the initial ultrasound (excluding patent foramen ovale, arterial duct <1.5 mm, and mild pulmonary stenosis, which are considered normal variations during the transition period).

Design outcomes

Primary

MeasureTime frame
Echocardiographic hemodynamic Indices(including RV FAC, RV CO, LVEF, MAPSE/TAPSE, LV CO, Mitral/Tricuspid early diastolic inflow velocity, Mitral/Tricuspid late diastolic inflow velocity , Patent ductus arteriosus size / Shunt direction, RVET, PAAT,etc.);Cerebral hemodynamic indices(including PSV, EDV,RI,PI);

Countries

China

Contacts

Public ContactJu Rong

Chengdu Women's and Children's Center Hospital

Jurong123@126.com+86 180 8010 3629

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026