Share on facebook Share on Twitter Share on Google Plus Share This
Back to Results

BPD-associated PH Observational Trial in Neonates


Title Development of Microfluidic Platforms to Non-Invasively Predict Bronchopulmonary Dysplasia (BPD) and BPD-associated Pulmonary Hypertension (PH) in Premature Neonates
Therapeutic Area Pulmonary Hypertension
Principal Investigator Anjali Iyengar, MD
Min Age 0 Years
Gender Both
Contact Anjali Iyengar
617-636-5322

Overview

This study is an observational study conducted over the first 18 months of life for preterm infants born less than 30 weeks’ gestation. We aim to develop transcriptomic (RNA), proteomic (protein), and metabolomic (protein-protein interaction) ‘foot-prints’ in blood, urine, and saliva of preterm infants who a) develop BPD; b) develop BPD with PH; and c) develop neither BPD or BPD with PH (control infants).

Study Details

Inclusion Criteria

  • Gestational age of 23 0/7 weeks to 30 0/7 weeks gestation
  • Admitted to Tufts Medical Center NICU
  • Less than 24hrs old

Exclusion Criteria

  • Congenital cardiac or pulmonary anomalies
  • Intra-uterine growth restriction
  • Genetic disorder

Study Requirements

Samples collected at birth are blood, saliva, and urine. Samples collected at 1 week of age are blood, saliva, and urine along with ECHO (heart ultrasound). Samples collected at 3 weeks are blood, saliva, and urine. Samples collected at 36 weeks post-menstrual age or prior to transfer to Level II Hospital are saliva and urine along with ECHO.

Additionally, we will be following subjects when they return for routine NICU Developmental visits 6 months after discharge home until they are 18 months of age. At these visits, study personnel (either PI, co-I, or research assistant) will interview mother/father and complete validated Respiratory Questionnaire. We will also be obtaining consent to contact parents on a monthly basis and will complete an abbreviated validated respiratory outcomes screening tool.

We will then compare the RNA, protein, and protein-protein 'footprints' from these fluid samples to breathing outcomes during hospitalization and long-term (until 18 months of age).