Prophylaxis of Patent Ductus Arteriosus with Paracetamol in Extremely Low Gestational Age Newborns (ELGANs): A Single-Institution Observational Study in Vietnam

Tinh Thu Nguyen; Dung Thi Ngoc Nguyen; Tam Thi Thanh Pham; Ju-Lee Oei

doi:10.3390/children10121934

Prophylaxis of Patent Ductus Arteriosus with Paracetamol in Extremely Low Gestational Age Newborns (ELGANs): A Single-Institution Observational Study in Vietnam

Children (Basel). 2023 Dec 17;10(12):1934. doi: 10.3390/children10121934.

Authors

Tinh Thu Nguyen^{1

2}, Dung Thi Ngoc Nguyen³, Tam Thi Thanh Pham⁴, Ju-Lee Oei^{5

6}

Affiliations

¹ Department of Pediatrics, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City 700000, Vietnam.
² Neonatal Intensive Care Unit, Children's Hospital 2, Ho Chi Minh City 700000, Vietnam.
³ Pediatric and Neonatology Department, Franco-Vietnamese Hospital, Ho Chi Minh City 700000, Vietnam.
⁴ Neonatal Intensive Care Unit, Children's Hospital 1, Ho Chi Minh City 700000, Vietnam.
⁵ School of Women's and Children's Health, Faculty of Medicine, University of New South Wales, Sydney, NSW 2031, Australia.
⁶ Department of Newborn Care, The Royal Hospital for Women, Randwick, Sydney, NSW 2031, Australia.

Abstract

Introduction: Prophylactic paracetamol for extremely low gestation age neonates (ELGAN, <27 weeks' gestation) with symptomatic patent ductus arteriosus (sPDA) in high-income countries (HIC) reduces medical and surgical interventions. Its effectiveness in low-to-middle-income countries (LMIC) remains uncertain. This study assesses prophylactic paracetamol's impact on sPDA interventions in ELGANs in an LMIC.

Methods: This is a retrospective cohort study that compared a historical cohort of ELGANs that were treated with oral ibuprofen or intravenous paracetamol after diagnosis of sPDA (n = 104) with infants (n = 76) treated with prophylactic paracetamol (20 mg/kg loading, 7.5 mg/kg qid for 4 days), in a tertiary neonatal intensive care unit (NICU) in Vietnam. Oral ibuprofen or intravenous therapeutic paracetamol were administered if prophylactic paracetamol failed to close sPDA. Surgical ligation was conducted if targeted medical intervention failed, or the infant deteriorated from conditions attributable to sPDA.

Results: In the historical cohort, 57 (55%) infants died within 7 days of life compared to 18 (24%) from the prophylactic cohort (p < 0.01). Of the survivors, 21 (45%) of the historical and 23 (39.7%) of the prophylactic cohort required surgical ligation (p = 0.6). Duration of hospitalization for survivors was lower in the prophylactic cohort (mean 74 vs. 97 days, p = 0.01). In the prophylactic cohort, 24 (41%) infants did not need further treatment while 34 (59%) required further treatment including ibuprofen and/or paracetamol 28 (48%) and surgical ligation 22 (38%).

Conclusions: Prophylactic paracetamol for ELGAN in LMIC does not reduce the need for surgical ligation, sPDA rates, and other PDA-related morbidities in infants who survive beyond 7 days of age. It may reduce the risk of death and the duration of hospitalization but further study into the reasons behind this need to be determined with larger studies.

Keywords: PDA closure; PDA ligation; paracetamol; patent ductus arteriosus; respiratory distress syndrome.

Grants and funding

This research received no external funding.