PDA Post NICU Discharge

Pediatrix

Status: Completed

Conditions: Patent Ductus Arteriosus

Study type: Observational

Funder types: Other

Identifiers

NCT02750228

PDX-002-15

Details and patient eligibility

About

The purpose of this study is to track post-discharge outcomes on prematurely born infants who are discharged from the NICU with a patent ductus arteriosus (PDA). Investigators plan to report on the spontaneous closure rate as well as the incidence of pulmonary and/or cardiac events in these infants. The goal is to identify risk factors associated with adverse outcomes in prematurely born infants who are sent home with a PDA.

Enrollment: 208 patients

Sex: All

Ages: 22 to 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documentation of informed consent and authorization for participation.
• Estimated gestational age of 32 weeks or less.
• Active diagnosis of a PDA at discharge.
• At least one echocardiogram obtained during hospital stay documenting/ confirming PDA diagnosis.
• Parental agreement to provide follow-up information on their child.
• Cardiologist and/or Pediatrician willing to provide follow-up information on enrolled infants.

Exclusion criteria

• No known major congenital anomalies (inborn error of metabolism, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, multiple congenital anomalies).
• Chromosomal / genetic disorders - Inherited metabolic disorders (Aa, fat or carbohydrate), Trisomies, Turner's syndrome,Vater's syndrome, CHARGE, DiGeorge or other 22q11 deletions, Major chromosomal duplications, deletions detectable on high resolution karyotype (not microarray).
• Parent(s) unwilling to participate in follow-up.