Presentation on theme: "DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS AT HIGH RISK OF"— Presentation transcript:
1DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS AT HIGH RISK OF RESPIRATORY DISTRESS SYNDROMEVermont Oxford Network
2DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTSSTEERING COMMITTEEJeanette M. Conner, PhD, MS Vermont Oxford NetworkAlan DeKlerk, MBChB, Maimonides Medical CenterRose DeKlerk RNC, New York Presbyterian Medical CenterMichael S. Dunn, MD, FRCPC, Sunnybrook & Women’s HospitalJoseph Kaempf, MD, Providence St. Vincent Medical CenterMaureen Reilly, RRCP, NRCP, Sunnybrook & Women’s HospitalRoger F. Soll, MD, Chair, Vermont Oxford NetworkEXPERT CONSULTANTJen-Tien Wung, MD, New York Presbyterian Medical Center
3DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTSPATIENT SAFETY AND DATA COMMITTEESteve Block, MD, ChairWake Forest University School of MedicineWalter Ambrosius, PhDArthur Kopelman, MDEast Carolina University
4DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS AT HIGH RISK OF RESPIRATORY DISTRESS SYNDROME:BACKGROUND and RATIONALE
5DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTSWhat is the best approach to take in the stabilization of premature infants at high risk of developing respiratory distress syndrome?delivery room intubation and prophylactic surfactantadministration with continued ventilator supportadministration without continued ventilator supportearly stabilization on nasal continuous positiveairway pressure (NCPAP)
6DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS What is current practice regarding intubation and surfactant administration for high risk infants (gestational age less than 30 weeks) in centers participating in the Vermont Oxford Network?
7SURFACTANT TREATMENT AND ENDOTRACHEAL INTUBATION BY GESTATIONAL AGE < >32Gestational Age (weeks)52,397 Infants 401 to 1500 Grams at 335 NICUS in 1998 and 1999
8DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS What is the rationale for early or prophylactic intubation and surfactant administration for high risk infants less than 30 weeks gestation?
9PROPHYLACTIC SURFACTANT ADMINISTRATION ADVANTAGES:improved distributiondecreased barotraumaneed for aggressiveresuscitation practiceincreased utilization/costDISADVANTAGES:
10EFFECT ON PNEUMOTHORAX PROPHYLACTIC vs. SELECTIVE SURFACTANTEFFECT ON PNEUMOTHORAXDecreasedRiskIncreasedSTUDY0.20.51.02.04.0Kendig 1991Dunn 1991Egberts 1993Kattwinkel 1993Walti 1995Bevilacqua 1996TYPICAL ESTIMATE0.20.51.02.04.0Soll 2001Relative Risk and 95% CI
11PROPHYLACTIC vs. SELECTIVE SURFACTANT EFFECT ON NEONATAL MORTALITY DecreasedRiskIncreasedSTUDY0.20.51.02.04.0Kendig 1991Dunn 1991Egberts 1993Kattwinkel 1993Walti 1995Bevilacqua 1996Bevilacqua 1997TYPICAL ESTIMATE0.20.51.02.04.0Soll 2001Relative Risk and 95% CI
12NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE What about the early application ofNasal Continuous Positive Airway Pressure (NCPAP)?
13NASAL CPAP and OUTCOME OF PRETERM INFANTS Comparison of clinical outcome before (n=57) and after (n=59) introduction of nasal continuous positive airway pressureDe Klerk AM and De Klerk RK. J Paediatr Child Health 2001
14PROPHYLACTIC APPLICATION OF NASAL CPAP RANDOMIZED CONTROLLED TRIAL OF 82 VLBW INFANTS(HAN AND COWORKERS 1987)Risk DifferenceDecreasedRiskIncreasedOUTCOME( 95% CI )0.20.51.02.04.0USE OF IPPV0.09 (-0.12, 0.29)PNEUMOTHORAX-0.01 (-0.14, 0.12)SEPSIS-0.04 (-0.21, 0.13)NECROTIZING ENTEROCOLITIS-0.14 (-0.30, 0.02)IVH0.15 (-0.02, 0.32)BRONCHOPULMONARY DYSPLASIA0.13 (-0.03, 0.29)MORTALITY0.07 (-0.03, 0.17)0.20.51.02.04.0HAN 1987Relative Risk and 95% CI
15DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS What is the rationale for considering early or prophylactic intubation and surfactant administration followed by rapid extubation and stabilization on nasal CPAP?
16NASAL CPAP AND EARLY SURFACTANT MECHANICAL VENTILATION OR DEATH VERDER H AND COWORKERS PEDIATRICS 1999
17NASAL CPAP AND EARLY SURFACTANT MORTALITYVERDER H AND COWORKERS PEDIATRICS 1999
18DELIVERY ROOM MANAGEMENT RESPIRATORY DISTRESS SYNDROME OF PREMATURE INFANTSAT HIGH RISK OFRESPIRATORY DISTRESS SYNDROMEPROTOCOL
19DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTSOBJECTIVETo compare the effect of three distinct methods of post-delivery stabilization and subsequent respiratory care on chronic lung disease and survival in premature infants at high risk of respiratory distress
20DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTSThe three approaches to post-delivery care:PS Group: Intubation, prophylactic surfactant administrationshortly after delivery, stabilization on ventilator supportNCPAP Group: Early stabilization on nasal continuous positiveairway pressure (NCPAP) with selective intubation andsurfactant administration for clinical indicationsISX Group: Intubation, prophylactic surfactantadministration, and rapid extubation to Nasal CPAP
21DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS : ENROLLMENT CRITERIA Eligibility: Admission to L & Dhigh risk of preterm delivery at gestational age 26+0 to 29+6 weeksInclusion Criteria:delivery imminentno maternal rupture of membranes > 14 daysno potentially life threatening congenital anomaly or genetic syndromeno known lung maturityantenatal steroid status knownwritten informed consent obtained (prior to delivery)Randomization: Prior to deliveryExclusion Criteria (s/p delivery):stillborn (apgar score of 0 at one minute)potentially life threatening congenital anomaly/genetic syndrome
22DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS STUDY DESIGNmulticenter randomized clinical trial conducted at participatingVermont Oxford Network Centers
23DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS : TREATMENT GROUPS Eligible infants will have consent obtained prior to delivery.At imminent delivery premature infants will be randomized to either:Intubation, prophylactic surfactant administration, subsequent stabilization on ventilator supportearly stabilization on NCPAP and selective intubation and surfactant administration for clinical indicationsintubation prophylactic surfactant administration and rapid extubation to NCPAP.After delivery infants who meet all criteria will be enrolled in the trial.
24DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS: TREATMENT GROUPS PROPHYLACTIC SURFACTANT ADMINISTRATION(PS GROUP)Intubation in the delivery room between five and fifteen minutes of lifeSurfactant treatment s/p intubationMechanical ventilationExtubation at anytime after 6 hours of age based on predefined criteria
25DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS: TREATMENT GROUPS EARLY APPLICATION OFNASAL CONTINUOUS POSITVE AIRWAY PRESSURE(NCPAP GROUP)Stabilization on standardized NCPAP system applied within five to fifteen minutes after deliveryBubble CPAP system at 5 cm H20Predefined criteria for respiratory insufficiency requiring intubation and surfactant treatment
26DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS: TREATMENT GROUPS PROPHYLACTIC SURFACTANT ADMINISTRATION,RAPID EXTUBATION TO NASAL CONTINUOUS POSITVE AIRWAY PRESSURE(ISX GROUP)Intubation in the delivery room between five and fifteen minutes of lifeSurfactant treatment s/p intubationRapid extubation to standardized nasal CPAP bubble system at 5 cm H20
27DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS CRITERIA FOR SELECTIVE INTUBATIONAND SURFACTANT TREATMENTIntubation based on clinical status:apnearespiratory failure (PCO2 > 65 mmHg)hypoxemia (supplemental oxygen > 40%-60%to maintain oxygen saturation > 86%-94%)severe respiratory distressSurfactant treatment s/p intubation
28DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS PRIMARY OUTCOME MEASURE:Chronic Lung Disease or Mortalityat 36 weeks adjusted ageChronic lung disease is defined as documentedrequirement for supplemental oxygen or respiratorysupport. Documented oxygen requirement will bedefined as the need for supplemental oxygen tomaintain an oxygen saturation 88%.
29DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS SAMPLE SIZE:Sample Size is based on:20% reduction in the number of infants with chronic lung disease/death from 36% to 29% ( 0.05, ß 0.2)A total of 2106 infants will be enrolled:702 per study groupWill re-evaluate based on results of pilot study
30DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS SECONDARY OUTCOME MEASURES:Number of infants receiving surfactant treatmentNumber of surfactant dosesPostnatal steroidsClinical status during first 28 days of lifeClinical status at 36 & 40 weeks adjusted ageDays on assisted ventilationDays on NCPAPDays on supplemental oxygenGrowth, day 28 and dischargePneumothoraxPulmonary hemorrhagePatent ductus arteriosusNecrotizing enterocolitisIntraventricular hemorrhageSteroids for chronic lung diseaseMortalityDuration of hospitalizationOther complications of prematurityHealth and developmental status at 2 years adjusted age
31DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS STUDY TIMELINEStudy to be conducted in three stagesStage 1: Introduction of Nasal CPAP in routine NICU practiceStage 2: Pilot study of feasibility of delivery room interventionsStage 3: Formal enrollment of subjects in large pragmatic trial
32DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS Stage 1: Introduction of Nasal CPAP in routine NICU practiceBuild bubble CPAP devicesEducate centers regarding use of bubble NCPAPIncorporate bubble NCPAP into daily routine of NICUEvaluate competence of centers in use of bubble CPAPFebruary through April 2003
33DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS Stage 2: Pilot study of feasibility of delivery room interventionsEducate centers regarding conduct of delivery room management trialPilot study of randomization to all three arms of studyMay through October 2003Determine feasibility of launching large pragmatic trial
34DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS Stage 3: Formal enrollment of subjects in large pragmatic trialIn accordance with insights gained from feasibility studyJanuary 2004
35DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS NETWORK CENTER PARTICIPATIONInterested centers must identify a study team comprised of a neonatologist, nurse practitioner or nurse, and a respiratory therapistTeam must commit to participating in a standardized education and training programTeam must implement education and training program within their NICU and unit must establish a level of competency with the bubble CPAP system prior to initiating enrollment in pilot study