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Association of Patent Ductus Arteriosus Ligation With Death or Neurodevelopmental Impairment Among Extremely Preterm Infants.
JAMA Pediatr. 2017 05 01; 171(5):443-449.JP

Abstract

Importance

Observational studies have associated patent ductus arteriosus (PDA) ligation among preterm infants with adverse neonatal outcomes and neurodevelopmental impairment in early childhood, with a resultant secular trend away from surgical treatment. However, to our knowledge, studies have inadequately addressed sources of residual bias, including survival bias and major neonatal morbidities arising before exposure to ligation.

Objective

Evaluate the association between PDA ligation vs medical management and neonatal and neurodevelopmental outcomes.

Design, Setting, and Participants

This retrospective cohort study of preterm infants younger than 28 weeks gestational age born between January 1, 2006, and December 31, 2012, with clinical and echocardiography diagnoses of hemodynamically significant PDA was conducted at 3 tertiary neonatal intensive care units and affiliated follow-up programs.

Exposure

Surgical ligation vs medical management.

Main Outcomes and Measures

The primary outcome was a composite of death or neurodevelopmental impairment (NDI) at 18 to 24 months corrected age. Secondary outcomes included death before discharge, NDI, moderate-severe chronic lung disease, and severe retinopathy of prematurity. Multivariable logistic regression analysis was used to adjust for perinatal and postnatal confounders.

Results

Of 754 infants with hemodynamically significant PDA (mean [standard deviation] gestational age 25.7 [1.2] weeks and birth weight 813 [183] grams), 184 (24%) underwent ligation. Infants who underwent ligation had a higher frequency of morbidities before PDA closure, including sepsis, necrotizing enterocolitis, and a dependence on mechanical ventilation. After adjusting for perinatal characteristics and preligation morbidities, there was no difference in the odds of death or NDI (adjusted odds ratio (aOR), 0.83; 95% CI, 0.52-1.32), NDI (aOR, 1.27; 95% CI, 0.78-2.06), chronic lung disease (aOR, 1.36; 95% CI, 0.78-2.39) or severe retinopathy of prematurity (aOR, 1.61; 95% CI, 0.85-3.06). Ligation was associated with lower odds of mortality (aOR, 0.09; 95% CI, 0.04-0.21).

Conclusions and Relevance

Patent ductus arteriosus ligation among preterm neonates younger than 28 weeks gestational age was not associated with the composite outcome of death or NDI, and there were no differences in chronic lung disease, retinopathy of prematurity, or NDI among survivors. Mortality was lower among infants who underwent ligation, though residual survival bias could not be excluded. Previously reported associations of ligation with increased morbidity may be because of bias from confounding by indication.

Authors+Show Affiliations

Department of Newborn and Developmental Pediatrics, Sunnybrook Health Sciences Centre, Toronto, Canada2Department of Pediatrics, University of Toronto, Toronto, Canada.Phoenix Children's Hospital, Phoenix, Arizona.Department of Pediatrics, Hospital for Sick Children, Toronto, Canada.Department of Pediatrics, Mt. Sinai Hospital, Toronto, Canada.Department of Pediatrics, University of Toronto, Toronto, Canada4Department of Pediatrics, Hospital for Sick Children, Toronto, Canada.Department of Newborn and Developmental Pediatrics, Sunnybrook Health Sciences Centre, Toronto, Canada2Department of Pediatrics, University of Toronto, Toronto, Canada.Department of Pediatrics, University of Toronto, Toronto, Canada5Department of Pediatrics, Mt. Sinai Hospital, Toronto, Canada.Department of Medicine, University of Toronto, Toronto, Canada.Department of Pediatrics, University of Toronto, Toronto, Canada5Department of Pediatrics, Mt. Sinai Hospital, Toronto, Canada.Department of Pediatrics, University of Toronto, Toronto, Canada4Department of Pediatrics, Hospital for Sick Children, Toronto, Canada7Department of Physiology, University of Toronto and Physiology and Experimental Medicine, SickKids Research Institute, Toronto, Canada.Department of Pediatrics, University of Toronto, Toronto, Canada5Department of Pediatrics, Mt. Sinai Hospital, Toronto, Canada8Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

28264088

Citation

Weisz, Dany E., et al. "Association of Patent Ductus Arteriosus Ligation With Death or Neurodevelopmental Impairment Among Extremely Preterm Infants." JAMA Pediatrics, vol. 171, no. 5, 2017, pp. 443-449.
Weisz DE, Mirea L, Rosenberg E, et al. Association of Patent Ductus Arteriosus Ligation With Death or Neurodevelopmental Impairment Among Extremely Preterm Infants. JAMA Pediatr. 2017;171(5):443-449.
Weisz, D. E., Mirea, L., Rosenberg, E., Jang, M., Ly, L., Church, P. T., Kelly, E., Kim, S. J., Jain, A., McNamara, P. J., & Shah, P. S. (2017). Association of Patent Ductus Arteriosus Ligation With Death or Neurodevelopmental Impairment Among Extremely Preterm Infants. JAMA Pediatrics, 171(5), 443-449. https://doi.org/10.1001/jamapediatrics.2016.5143
Weisz DE, et al. Association of Patent Ductus Arteriosus Ligation With Death or Neurodevelopmental Impairment Among Extremely Preterm Infants. JAMA Pediatr. 2017 05 1;171(5):443-449. PubMed PMID: 28264088.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Association of Patent Ductus Arteriosus Ligation With Death or Neurodevelopmental Impairment Among Extremely Preterm Infants. AU - Weisz,Dany E, AU - Mirea,Lucia, AU - Rosenberg,Erin, AU - Jang,Maximus, AU - Ly,Linh, AU - Church,Paige T, AU - Kelly,Edmond, AU - Kim,S Joseph, AU - Jain,Amish, AU - McNamara,Patrick J, AU - Shah,Prakesh S, PY - 2017/3/7/pubmed PY - 2017/7/14/medline PY - 2017/3/7/entrez SP - 443 EP - 449 JF - JAMA pediatrics JO - JAMA Pediatr VL - 171 IS - 5 N2 - Importance: Observational studies have associated patent ductus arteriosus (PDA) ligation among preterm infants with adverse neonatal outcomes and neurodevelopmental impairment in early childhood, with a resultant secular trend away from surgical treatment. However, to our knowledge, studies have inadequately addressed sources of residual bias, including survival bias and major neonatal morbidities arising before exposure to ligation. Objective: Evaluate the association between PDA ligation vs medical management and neonatal and neurodevelopmental outcomes. Design, Setting, and Participants: This retrospective cohort study of preterm infants younger than 28 weeks gestational age born between January 1, 2006, and December 31, 2012, with clinical and echocardiography diagnoses of hemodynamically significant PDA was conducted at 3 tertiary neonatal intensive care units and affiliated follow-up programs. Exposure: Surgical ligation vs medical management. Main Outcomes and Measures: The primary outcome was a composite of death or neurodevelopmental impairment (NDI) at 18 to 24 months corrected age. Secondary outcomes included death before discharge, NDI, moderate-severe chronic lung disease, and severe retinopathy of prematurity. Multivariable logistic regression analysis was used to adjust for perinatal and postnatal confounders. Results: Of 754 infants with hemodynamically significant PDA (mean [standard deviation] gestational age 25.7 [1.2] weeks and birth weight 813 [183] grams), 184 (24%) underwent ligation. Infants who underwent ligation had a higher frequency of morbidities before PDA closure, including sepsis, necrotizing enterocolitis, and a dependence on mechanical ventilation. After adjusting for perinatal characteristics and preligation morbidities, there was no difference in the odds of death or NDI (adjusted odds ratio (aOR), 0.83; 95% CI, 0.52-1.32), NDI (aOR, 1.27; 95% CI, 0.78-2.06), chronic lung disease (aOR, 1.36; 95% CI, 0.78-2.39) or severe retinopathy of prematurity (aOR, 1.61; 95% CI, 0.85-3.06). Ligation was associated with lower odds of mortality (aOR, 0.09; 95% CI, 0.04-0.21). Conclusions and Relevance: Patent ductus arteriosus ligation among preterm neonates younger than 28 weeks gestational age was not associated with the composite outcome of death or NDI, and there were no differences in chronic lung disease, retinopathy of prematurity, or NDI among survivors. Mortality was lower among infants who underwent ligation, though residual survival bias could not be excluded. Previously reported associations of ligation with increased morbidity may be because of bias from confounding by indication. SN - 2168-6211 UR - https://www.unboundmedicine.com/medline/citation/28264088/Association_of_Patent_Ductus_Arteriosus_Ligation_With_Death_or_Neurodevelopmental_Impairment_Among_Extremely_Preterm_Infants_ L2 - https://jamanetwork.com/journals/jamapediatrics/fullarticle/10.1001/jamapediatrics.2016.5143 DB - PRIME DP - Unbound Medicine ER -