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  1. Article ; Online: Prophylactic Indomethacin in Infants Born Extremely Preterm: Risks and Benefits Revisited.

    Clyman, Ronald I

    The Journal of pediatrics

    2023  Volume 260, Page(s) 113568

    MeSH term(s) Infant, Newborn ; Infant ; Humans ; Indomethacin/therapeutic use ; Infant, Extremely Premature ; Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Ductus Arteriosus, Patent ; Risk Assessment
    Chemical Substances Indomethacin (XXE1CET956) ; Anti-Inflammatory Agents, Non-Steroidal
    Language English
    Publishing date 2023-06-15
    Publishing country United States
    Document type Editorial ; Research Support, N.I.H., Extramural ; Comment
    ZDB-ID 3102-1
    ISSN 1097-6833 ; 0022-3476
    ISSN (online) 1097-6833
    ISSN 0022-3476
    DOI 10.1016/j.jpeds.2023.113568
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  2. Article ; Online: Prophylactic indomethacin and the risk of serious pulmonary hemorrhages in preterm infants less than 28 weeks' gestation.

    Clyman, Ronald I / Hills, Nancy K

    Journal of perinatology : official journal of the California Perinatal Association

    2024  

    Abstract: Objective: To determine if prophylactic indomethacin (PINDO) decreases serious pulmonary hemorrhages in infants <28 weeks.: Study design: Intention-to-treat analysis of 615 consecutively admitted infants during four alternating protocol-driven epochs ...

    Abstract Objective: To determine if prophylactic indomethacin (PINDO) decreases serious pulmonary hemorrhages in infants <28 weeks.
    Study design: Intention-to-treat analysis of 615 consecutively admitted infants during four alternating protocol-driven epochs of PINDO or expectant patent ductus arteriosus (PDA) management.
    Results: 41/615 (6.7%) developed serious pulmonary hemorrhage at 2 (1, 3) days (median (IQR)). In unadjusted and adjusted multivariable models, infants born in a PINDO epoch had significantly lower incidences of pulmonary hemorrhage and pulmonary hemorrhage or death before 7 days. There were less moderate/large PDA during PINDO epochs. The associations between PINDO and pulmonary hemorrhage and pulmonary hemorrhage/death were no longer significant when presence of a PDA was included in the analyses. There was no apparent association between PINDO epochs and the incidence of serious intraventricular hemorrhages.
    Conclusion: Even though PINDO no longer appears to affect the incidence of sIVH it still is associated with a lower incidence of pulmonary hemorrhage.
    Language English
    Publishing date 2024-04-24
    Publishing country United States
    Document type Journal Article
    ZDB-ID 645021-0
    ISSN 1476-5543 ; 0743-8346
    ISSN (online) 1476-5543
    ISSN 0743-8346
    DOI 10.1038/s41372-024-01971-x
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  3. Article ; Online: Reply.

    Clyman, Ronald I

    The Journal of pediatrics

    2021  Volume 234, Page(s) 291–292

    MeSH term(s) Bronchopulmonary Dysplasia ; Causality ; Humans ; Infant, Newborn
    Language English
    Publishing date 2021-03-22
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 3102-1
    ISSN 1097-6833 ; 0022-3476
    ISSN (online) 1097-6833
    ISSN 0022-3476
    DOI 10.1016/j.jpeds.2021.03.031
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  4. Article ; Online: Patent ductus arteriosus (PDA) and pulmonary morbidity: can early targeted pharmacologic PDA treatment decrease the risk of bronchopulmonary dysplasia?

    Clyman, Ronald I / Hills, Nancy K

    Seminars in perinatology

    2023  Volume 47, Issue 2, Page(s) 151718

    Abstract: A persistent left-to-right shunt through a patent ductus arteriosus (PDA) increases the rate of pulmonary hydrostatic fluid filtration, impairs pulmonary mechanics, and prolongs the need for respiratory support. Infants with a moderate/large PDA shunt ... ...

    Abstract A persistent left-to-right shunt through a patent ductus arteriosus (PDA) increases the rate of pulmonary hydrostatic fluid filtration, impairs pulmonary mechanics, and prolongs the need for respiratory support. Infants with a moderate/large PDA shunt that persists for more than 7-14 days are at increased risk for developing bronchopulmonary dysplasia (BPD) if they also require invasive ventilation for more than 10 days. In contrast, infants who require invasive ventilation for less than 10 days have similar rates of BPD no matter how long they are exposed to a moderate/large PDA shunt. Although pharmacologic PDA closure decreases the risk of abnormal early alveolar development in preterm baboons that are ventilated for 2 weeks, the findings from recent randomized controlled trials, as well as a quality improvement project, suggest that routine early targeted pharmacologic treatments, as currently employed, do not appear to alter the incidence of BPD in human infants.
    MeSH term(s) Infant, Newborn ; Humans ; Ductus Arteriosus, Patent/drug therapy ; Bronchopulmonary Dysplasia/prevention & control ; Bronchopulmonary Dysplasia/etiology ; Incidence
    Language English
    Publishing date 2023-03-01
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 752403-1
    ISSN 1558-075X ; 0146-0005
    ISSN (online) 1558-075X
    ISSN 0146-0005
    DOI 10.1016/j.semperi.2023.151718
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  5. Article ; Online: Prophylactic indomethacin, antenatal betamethasone, and the risk of intestinal perforation in infants <28 weeks' gestation.

    Clyman, Ronald I / Hills, Nancy K

    Journal of perinatology : official journal of the California Perinatal Association

    2023  Volume 43, Issue 10, Page(s) 1252–1261

    Abstract: Objective: To determine if intestinal perforations before 14 days (either spontaneous (SIP) or necrotizing enterocolitis-induced) are increased when infants who received antenatal betamethasone shortly before birth are treated with prophylactic ... ...

    Abstract Objective: To determine if intestinal perforations before 14 days (either spontaneous (SIP) or necrotizing enterocolitis-induced) are increased when infants who received antenatal betamethasone shortly before birth are treated with prophylactic indomethacin (PINDO).
    Study design: Observational study of 475 infants <28 week's gestation assigned to either a PINDO-protocol (n = 231) or expectant management protocol (n = 244) during consecutive protocol epochs.
    Results: Intestinal perforations before 14 days occurred in 33/475 (7%). In unadjusted and adjusted models, we found no associations between PINDO-protocol and intestinal perforations. PINDO-protocol did not increase intestinal perforations or SIP-alone even when given to infants who received betamethasone <7 or <2 days before delivery. 213/231 (92%) PINDO-protocol infants actually received indomethacin. The results were unchanged when examined just in those who received indomethacin.
    Conclusion: In our study, early intestinal perforations and SIP-alone were not increased when PINDO was used by protocol in infants who received antenatal betamethasone shortly before birth.
    MeSH term(s) Infant, Newborn ; Humans ; Infant ; Female ; Pregnancy ; Indomethacin/adverse effects ; Betamethasone/adverse effects ; Intestinal Perforation/chemically induced ; Retrospective Studies ; Enterocolitis, Necrotizing/prevention & control
    Chemical Substances Indomethacin (XXE1CET956) ; Betamethasone (9842X06Q6M)
    Language English
    Publishing date 2023-03-27
    Publishing country United States
    Document type Observational Study ; Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 645021-0
    ISSN 1476-5543 ; 0743-8346
    ISSN (online) 1476-5543
    ISSN 0743-8346
    DOI 10.1038/s41372-023-01653-0
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  6. Article ; Online: Effects of prophylactic indomethacin on morbidity and mortality in infants <25 weeks' gestation: a protocol driven intention to treat analysis.

    Clyman, Ronald I / Hills, Nancy K

    Journal of perinatology : official journal of the California Perinatal Association

    2022  Volume 42, Issue 12, Page(s) 1662–1668

    Abstract: Objective: To determine if prophylactic indomethacin (PINDO) decreases death or bronchopulmonary dysplasia-grades 2 and 3 (death/BPD) in newborns <25 weeks.: Study design: Intention-to-treat, cohort-controlled study of 106 infants admitted during ... ...

    Abstract Objective: To determine if prophylactic indomethacin (PINDO) decreases death or bronchopulmonary dysplasia-grades 2 and 3 (death/BPD) in newborns <25 weeks.
    Study design: Intention-to-treat, cohort-controlled study of 106 infants admitted during three alternating epochs of PINDO or Expectant patent ductus arteriosus (PDA) management.
    Results: At 7-8 days 85% of Expectant Management epoch infants had a moderate/large PDA (median exposure was 23 days). Among PINDO epoch infants only 24% still had a PDA at 7-8 days. There were no significant differences in the incidence of death/BPD or of secondary outcomes (BPD, death, necrotizing enterocolitis/spontaneous perforations, or intraventricular hemorrhage (grades 3 or 4)) in either unadjusted or adjusted comparisons between infants born in a PINDO epoch and those born in the Expectant Management epoch.
    Conclusion: Despite being at high risk for PDA-related morbidities, PINDO did not appear to alter the rates of our primary and secondary outcomes in infants <25 weeks.
    MeSH term(s) Infant, Newborn ; Humans ; Pregnancy ; Female ; Indomethacin/therapeutic use ; Intention to Treat Analysis ; Ductus Arteriosus, Patent/complications ; Gestational Age ; Incidence
    Chemical Substances Indomethacin (XXE1CET956)
    Language English
    Publishing date 2022-10-30
    Publishing country United States
    Document type Journal Article
    ZDB-ID 645021-0
    ISSN 1476-5543 ; 0743-8346
    ISSN (online) 1476-5543
    ISSN 0743-8346
    DOI 10.1038/s41372-022-01547-7
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  7. Article ; Online: Patent ductus arteriosus and the risk of bronchopulmonary dysplasia-associated pulmonary hypertension.

    Nawaytou, Hythem / Hills, Nancy K / Clyman, Ronald I

    Pediatric research

    2023  Volume 94, Issue 2, Page(s) 547–554

    Abstract: Background: The aim of the study was to determine whether prolonged exposure to a moderate/large patent ductus arteriosus left-to-right shunt (PDA) increases the risk of late (beyond 36 weeks) pulmonary hypertension (BPD-PH) and pulmonary vascular ... ...

    Abstract Background: The aim of the study was to determine whether prolonged exposure to a moderate/large patent ductus arteriosus left-to-right shunt (PDA) increases the risk of late (beyond 36 weeks) pulmonary hypertension (BPD-PH) and pulmonary vascular disease (BPD-PVD) during the neonatal hospitalization in preterm infants (<28 weeks' gestation) with bronchopulmonary dysplasia (BPD).
    Methods: All infants requiring respiratory support ≥36 weeks had systematic echocardiographic evaluations for BPD-PH at planned intervals. Infants were classified as having either flow-associated BPD-PH (BPD-flow-PH) or BPD-PVD.
    Results: 256 infants survived ≥36 weeks: 105 had NO BPD (were off respiratory support by 36 weeks); 151 had BPD. 22/151 had BPD-PH (12/22 had BPD-flow-PH from a PDA that persisted beyond 36 weeks; 10/22 had BPD-PVD). Moderate/large PDA shunts that persisted beyond 36 weeks were significantly associated with an increased incidence of BPD-PH due to BPD-flow-PH. We found no association between the duration of PDA exposure and the incidence of BPD-PVD.
    Conclusions: Moderate/large PDA shunts increase the risk of flow-associated BPD-PH when present beyond 36 weeks. Although term infants with PDA-congenital heart disease can develop pulmonary vascular remodeling and PVD after months of PDA exposure, we found no echocardiographic evidence in preterm infants that prolonged PDA exposure increases the incidence of BPD-PVD during the neonatal hospitalization.
    Impact: In our study, preterm infants (<28 weeks' gestation) with bronchopulmonary dysplasia (BPD) had a 15% incidence of pulmonary hypertension (PH) beyond 36 weeks' postmenstrual age as a comorbidity. Moderate/large patent ductus arteriosus (PDA) shunts increased the risk of flow-associated PH when present beyond 36 weeks. Although months of prolonged PDA exposure can cause pulmonary vascular remodeling and pulmonary vascular disease (PVD) in term infants with PDA-congenital heart disease, we found no echocardiographic evidence for an association between the duration of PDA exposure and the incidence of late PVD during the neonatal hospitalization in preterm infants with BPD.
    MeSH term(s) Infant ; Infant, Newborn ; Humans ; Bronchopulmonary Dysplasia/etiology ; Infant, Premature ; Ductus Arteriosus, Patent/complications ; Hypertension, Pulmonary/complications ; Vascular Remodeling ; Pulmonary Arterial Hypertension/complications
    Language English
    Publishing date 2023-02-17
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 4411-8
    ISSN 1530-0447 ; 0031-3998
    ISSN (online) 1530-0447
    ISSN 0031-3998
    DOI 10.1038/s41390-023-02522-4
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  8. Article ; Online: Patent ductus arteriosus, its treatments, and the risks of pulmonary morbidity.

    Clyman, Ronald I

    Seminars in perinatology

    2018  Volume 42, Issue 4, Page(s) 235–242

    Abstract: A persistent left-to-right shunt through a patent ductus arteriosus (PDA) increases the rate of hydrostatic fluid filtration into the lung's interstitium, impairs pulmonary mechanics, and prolongs the need for mechanical ventilation. In preclinical ... ...

    Abstract A persistent left-to-right shunt through a patent ductus arteriosus (PDA) increases the rate of hydrostatic fluid filtration into the lung's interstitium, impairs pulmonary mechanics, and prolongs the need for mechanical ventilation. In preclinical trials, pharmacologic PDA closure leads to improved alveolarization and minimizes the impaired postnatal alveolar development that is the pathologic hallmark of bronchopulmonary dysplasia (BPD). Although routine prophylactic treatment of a PDA on the day of birth does not appear to offer any more protection against BPD than delaying treatment for 2-3 days, recent evidence from quality improvement trials suggests that early pharmacologic treatment decreases the incidence of BPD compared with a treatment approach that exposes infants to a moderate-to-large PDA shunt for the first 7-10 days after birth. After the first week, routine pharmacologic treatment (compared with continued PDA exposure) no longer appears to alter the course of BPD development. Evidence from epidemiologic, preclinical, and randomized controlled trials demonstrate that early ductus ligation is an independent risk factor for the development of BPD.
    MeSH term(s) Age Factors ; Bronchopulmonary Dysplasia/etiology ; Bronchopulmonary Dysplasia/physiopathology ; Ductus Arteriosus, Patent/physiopathology ; Ductus Arteriosus, Patent/surgery ; Humans ; Infant, Newborn ; Infant, Premature ; Ligation/adverse effects ; Ligation/methods ; Observational Studies as Topic ; Randomized Controlled Trials as Topic ; Respiration, Artificial/statistics & numerical data ; Retrospective Studies ; Risk Factors
    Language English
    Publishing date 2018-05-10
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 752403-1
    ISSN 1558-075X ; 0146-0005
    ISSN (online) 1558-075X
    ISSN 0146-0005
    DOI 10.1053/j.semperi.2018.05.006
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  9. Article ; Online: The effect of prolonged tracheal intubation on the association between patent ductus arteriosus and bronchopulmonary dysplasia (grades 2 and 3).

    Clyman, Ronald I / Hills, Nancy K

    Journal of perinatology : official journal of the California Perinatal Association

    2020  Volume 40, Issue 9, Page(s) 1358–1365

    Abstract: Objective: To determine if the need for mechanical ventilation alters the association between prolonged patent ductus arteriosus (PDA) exposure and bronchopulmonary dysplasia (grades 2 and 3) (BPD).: Study design: Observational study of 407 infants (< ...

    Abstract Objective: To determine if the need for mechanical ventilation alters the association between prolonged patent ductus arteriosus (PDA) exposure and bronchopulmonary dysplasia (grades 2 and 3) (BPD).
    Study design: Observational study of 407 infants (<28 weeks' gestation) with echocardiograms performed at planned intervals.
    Results: Twelve percent (48/407) of study infants had BPD (grades 2 and 3). In a multivariable regression model, exposure to a moderate-to-large PDA shunt for ≥7 days was associated with an increased risk of BPD (grades 2 and 3) (from 16 to 35%: aRD = 19% (6, 32%), p < 0.005) when infants required ≥10 days of intubation (n = 170). In contrast, there was no significant association between prolonged PDA exposure and BPD when infants required ≤9 days of intubation (aRD = 4%) (-1, 10%) (n = 237).
    Conclusions: Moderate-to-large PDAs are associated with an increased risk of BPD-but only when infants require intubation ≥10 days.
    MeSH term(s) Bronchopulmonary Dysplasia/epidemiology ; Bronchopulmonary Dysplasia/etiology ; Ductus Arteriosus, Patent/diagnostic imaging ; Gestational Age ; Humans ; Infant ; Infant, Newborn ; Intubation, Intratracheal/adverse effects ; Respiration, Artificial/adverse effects
    Language English
    Publishing date 2020-07-15
    Publishing country United States
    Document type Journal Article ; Observational Study ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 645021-0
    ISSN 1476-5543 ; 0743-8346
    ISSN (online) 1476-5543
    ISSN 0743-8346
    DOI 10.1038/s41372-020-0718-x
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  10. Article ; Online: Management of persistent ductus arteriosus in very premature neonates. Results of the French TRIOCAPI trial, perspectives for clinicians, and subsequent studies on this topic.

    Cambonie, G / Clyman, Ronald I / Rozé, J-C

    Archives de pediatrie : organe officiel de la Societe francaise de pediatrie

    2021  Volume 28, Issue 7, Page(s) 501–503

    MeSH term(s) Clinical Trials as Topic ; Ductus Arteriosus ; Ductus Arteriosus, Patent/drug therapy ; Humans ; Infant, Newborn ; Infant, Premature
    Language English
    Publishing date 2021-09-09
    Publishing country France
    Document type Editorial
    ZDB-ID 1181947-9
    ISSN 1769-664X ; 0929-693X
    ISSN (online) 1769-664X
    ISSN 0929-693X
    DOI 10.1016/j.arcped.2021.07.002
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