Prof. Dr. Haresh Kirpalani
University of Pennsylvania, USA and McMaster University, Ontario, Canada
I am an emeritus professor at both University Pennsylvania, USA and McMaster University, Canada. I am a neonatal physician trained from medical school to advanced fellow status in the UK; with further training at Toronto Hospital Sick Children, Canada. I am MSc qualified in Clinical Epidemiology (McMaster University). At McMaster University, I helped establish the Neonatal Research group out of the Department of Clinical Epidemiology & Biostatistics (led and co-founded by myself, Barbara Schmidt, and Robin Roberts). Since 2007 I worked mainly in the USA at The Children’s Hospital of Philadelphia. I was the founding Director of the Chronic Lung Disease Program at Children’s Hospital of Philadelphia. I am committed to mentoring junior researchers and clinicians. I was fortunate to receive several teaching and mentoring awards – the last being in 2015 – an award for Junior Faculty mentoring at Children’s Hospital Philadelphia. I have been involved with randomized controlled trials (RCT) in either the neonatal ICU or the pediatric ICU since 1985. This involvement includes service on several data safety monitoring committees for RCTs. I remain a passionate advocate of Evidence Based Medicine in neonatal trials, which I interpret as an imperative to have more high quality randomized evidence of therapies in the NICU. I was on the foundation editorial founding board of an international organization “Evidence Based Neonatology” (https://ebneo.org/).
Prior RCT work was funded by the Canadian Institute of Health Research (CIHR) and I then held current NIHCHD and NHLBI funding. I was also the alternate PI to the Neonatal Research Network of the NICHD at the University of Pennsylvania, of which Dr. Barbara Schmidt was the PI. My RCT experience began in 1985, as the trial coordinator at the Hospital for Sick Children for the High Frequency Oscillation (HiFi) study. I was a steering committee member for 2 major neonatal trials of inhaled nitric oxide funded by the Canadian Institute of Health Research and in which the Neonatal Research Network of the NICHD took part: the Neonatal Inhaled Nitric Oxide Study (NiNOS) and the Early Inhaled Nitric Oxide Study (EiNOS) trials. I was the PI of a multinational randomized controlled trial – funded by Canadian Institute of Health Research (CIHR): Nasal Intermittent Positive Pressure Ventilation trial NIPPV - comparing CPAP vs nasal IPPV non-invasive respiratory support, which enrolled 1012 infants of BW <1000 g.
I was the PI of a multi-national trial on the effects of Sustained Inflation in the delivery room in preterms (Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial). This is now published JAMA 2019 (see below), and has explicitly informed and been quoted by the most recent European Guidelines for resuscitation. I was also the PI of the Preterms In Need of Transfusion (PINT) study, funded by the CIHR. This was the largest neonatal RCT to examine whether random allocation to two different hemoglobin thresholds affect clinically relevant neonatal outcomes in infants with birth weights <1000 g. A further CIHR funded project (PINT-Outcome Study) followed these infants to 24 months to assess longer term outcomes. The PINT-Outcome trial, in secondary post-hoc analyses, showed a possible benefit to a higher hemoglobin regimen. That set the stage for the large trial “Transfusion of Prematurity (TOP trial). I was the contact PI of the TOP trial, funded by NHLBI to randomize 1824 babies <1000 g BW to high or low hemoglobin transfusion thresholds. TOP had a primary outcomes of death or neurodevelopment by 2 years of age. The TOP trial was published in the NEJM as listed below.
1. Kirpalani H, Bell EF, Hintz SR, Tan S, Schmidt B, Chaudhary AS, Johnson KJ, Crawford MM, Newman JE, Vohr BR, Carlo WA, D'Angio CT, Kennedy KA, Ohls RK, Poindexter BB, Schibler K, Whyte RK, Widness JA, Zupancic JAF, Wyckoff MH, Truog WE, Walsh MC, Chock VY, Laptook AR, Sokol GM, Yoder BA, Patel RM, Cotten CM, Carmen MF, Devaskar U, Chawla S, Seabrook R, Higgins RD, Das A; Eunice Kennedy Shriver NICHD Neonatal Research Network. Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants. N Engl J Med. 2020 Dec 31;383(27):2639-2651
2. Kirpalani H, Ratcliffe SJ, Keszler M, Davis PG, Foglia EE, Te Pas A, Fernando M, Chaudhary A, Localio R, van Kaam AH, Onland W, Owen LS, Schmölzer GM, Katheria A, Hummler H, Lista G, Abbasi S, Klotz D, Simma B, Nadkarni V, Poulain FR, Donn SM, Kim HS, Park WS, Cadet C, Kong JY, Smith A, Guillen U, Liley HG, Hopper AO, Tamura M; SAIL Site Investigators. Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants: The SAIL Randomized Clinical Trial. JAMA. 2019 Mar 26;321(12):1165-1175.
3. Kirpalani H, Millar D, Lemyre B, Yoder BA, Chiu A, Roberts RS; NIPPV Study Group. A trial comparing noninvasive ventilation strategies in preterm infants. N Engl J Med. 2013 Aug15; 369(7): 611-20.
4. Kirpalani H, Whyte RK, Andersen C, Asztalos EV, Heddle N, Blajchman MA, Peliowski A, Rios A, LaCorte M, Connelly R, Barrington K, Roberts RS. The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) versus liberal (high) transfusion threshold for extremely low birth weight infants. J Pediatr. 2006 Sep; 149(3):301-307.