Patent ductus arteriosus and Left Atrial Size Evaluation study in preterm infants (multicenter prospective observational cohort study without interventions)

Patent ductus arteriosus and Left Atrial Size Evaluation study in preterm infants (multicenter prospective observational cohort study without interventions) - PLASE study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016280

Enrollment

500

Registered

2015-02-28

Start date

2015-03-15

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

preterm infants

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Neonates with gestational age at birth between 23 weeks & 0 day and 29 weeks & 6 days, and 2)Neonates who admitted to the NICUs participating in this study until 24 hours after birth, and 3)Neonates who survived 24 hours after birth.

Exclusion criteria

Exclusion criteria: Chromosomal abnormality:(13, 18, 21 trisomy, del 22q11.2, Noonan syndrome, etc). Multiple anomalies, apparent clinical syndrome, congenital anomalies which needs operation during infancy. Congenital heart disease other than PDA/PFO/PLSVC. Congenital metabolic disease, endocrinologic disease, neuromuscular disease, systemic bone disease. Family history of severe heredity disease such as neuromuscular disease or cardiomyopathy. Neonates whose parents do not agree to provide the patients' data to the study. Critical condition ineligible for this study, which was judged by attending physician.

Design outcomes

Primary

Measure	Time frame
PDA surgery	—

Secondary

Measure	Time frame
Symptomatic PDA The number of COX inhibitor administration Intraventricular hemorrhage (grade I-II) Intraventricular hemorrhage (grade III- IV) Pulmonary hemorrhage necessitating therapy Intestinal perforation Necrotizing enterocolitis Chronic lung disease with moderate severity (FiO2<0.3, and no respiratory pressure support at 36 weeks of gestation) Severe chronic lung disease (FiO2>=0.3, or respiratory pressure support at 36 weeks of gestation) Severe retinopathy of prematurity(>= Stage3 of type I, or type 2 in Japanese criteria; or >=Stage 3 in international criteria; or who needs therapy for retinopathy)	—

Measure

Time frame

Symptomatic PDA The number of COX inhibitor administration Intraventricular hemorrhage (grade I-II) Intraventricular hemorrhage (grade III- IV) Pulmonary hemorrhage necessitating therapy Intestinal perforation Necrotizing enterocolitis Chronic lung disease with moderate severity (FiO2<0.3, and no respiratory pressure support at 36 weeks of gestation) Severe chronic lung disease (FiO2>=0.3, or respiratory pressure support at 36 weeks of gestation) Severe retinopathy of prematurity(>= Stage3 of type I, or type 2 in Japanese criteria; or >=Stage 3 in international criteria; or who needs therapy for retinopathy)

—

Countries

Japan

Contacts

Public ContactSatoshi Masutani

Saitama Medical University Pediatric Cardiology

smstn@ka2.so-net.ne.jp049-228-3400

Outcome results