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DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS AT HIGH RISK OF AT HIGH RISK OF RESPIRATORY DISTRESS SYNDROME Vermont Oxford Network.

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Presentation on theme: "DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS AT HIGH RISK OF AT HIGH RISK OF RESPIRATORY DISTRESS SYNDROME Vermont Oxford Network."— Presentation transcript:

1 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS AT HIGH RISK OF AT HIGH RISK OF RESPIRATORY DISTRESS SYNDROME Vermont Oxford Network

2 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS STEERING COMMITTEE Jeanette M. Conner, PhD, MS Vermont Oxford Network Alan DeKlerk, MBChB, Maimonides Medical Center Rose DeKlerk RNC, New York Presbyterian Medical Center Michael S. Dunn, MD, FRCPC, Sunnybrook & Womens Hospital Joseph Kaempf, MD, Providence St. Vincent Medical Center Maureen Reilly, RRCP, NRCP, Sunnybrook & Womens Hospital Roger F. Soll, MD, Chair, Vermont Oxford Network EXPERT CONSULTANT EXPERT CONSULTANT Jen-Tien Wung, MD, New York Presbyterian Medical Center

3 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS PATIENT SAFETY AND DATA COMMITTEE Steve Block, MD, Chair Wake Forest University School of Medicine Walter Ambrosius, PhD Wake Forest University School of Medicine Arthur Kopelman, MD East Carolina University

4 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS AT HIGH RISK OF AT HIGH RISK OF RESPIRATORY DISTRESS SYNDROME: BACKGROUND and RATIONALE

5 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS What 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 surfactant delivery room intubation and prophylactic surfactant administration with continued ventilator support administration with continued ventilator support delivery room intubation and prophylactic surfactant delivery room intubation and prophylactic surfactant administration without continued ventilator support administration without continued ventilator support early stabilization on nasal continuous positive early stabilization on nasal continuous positive airway pressure (NCPAP) airway pressure (NCPAP)

6 DELIVERY 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?

7 Gestational Age (weeks) SURFACTANT TREATMENT AND ENDOTRACHEAL INTUBATION BY GESTATIONAL AGE 52,397 Infants 401 to 1500 Grams at 335 NICUS in 1998 and

8 DELIVERY 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?

9 PROPHYLACTIC SURFACTANT ADMINISTRATION improved distribution improved distribution decreased barotrauma decreased barotrauma need for aggressive need for aggressive resuscitation practice resuscitation practice increased utilization/cost increased utilization/cost ADVANTAGES: DISADVANTAGES:

10 Relative Risk and 95% CI STUDY DecreasedIncreasedRisk PROPHYLACTIC vs. SELECTIVE SURFACTANT Dunn 1991 EFFECT ON PNEUMOTHORAX Egberts 1993 Kattwinkel 1993 Walti 1995 Bevilacqua 1996 Soll 2001 TYPICAL ESTIMATE Kendig 1991

11 Relative Risk and 95% CI STUDY DecreasedIncreasedRisk PROPHYLACTIC vs. SELECTIVE SURFACTANT Dunn 1991 EFFECT ON NEONATAL MORTALITY Egberts 1993 Kattwinkel 1993 Walti 1995 Bevilacqua 1996 Soll 2001 TYPICAL ESTIMATE Kendig 1991 Bevilacqua 1997

12 NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE What about the early application of Nasal Continuous Positive Airway Pressure (NCPAP)?

13 De Klerk AM and De Klerk RK. J Paediatr Child Health 2001 NASAL CPAP and OUTCOME OF PRETERM INFANTS Comparison of clinical outcome before (n=57) and after (n=59) introduction of nasal continuous positive airway pressure

14 Relative Risk and 95% CI OUTCOME Risk Difference ( 95% CI ) DecreasedIncreasedRisk PROPHYLACTIC APPLICATION OF NASAL CPAP RANDOMIZED CONTROLLED TRIAL OF 82 VLBW INFANTS (HAN AND COWORKERS 1987) PNEUMOTHORAX (-0.14, 0.12) SEPSIS (-0.21, 0.13) IVH BRONCHOPULMONARY DYSPLASIA 0.13 (-0.03, 0.29) MORTALITY 0.07 (-0.03, 0.17) USE OF IPPV NECROTIZING ENTEROCOLITIS 0.09 (-0.12, 0.29) (-0.30, 0.02) 0.15 (-0.02, 0.32) HAN 1987

15 DELIVERY 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?

16 VERDER H AND COWORKERS PEDIATRICS 1999 NASAL CPAP AND EARLY SURFACTANT MECHANICAL VENTILATION OR DEATH

17 VERDER H AND COWORKERS PEDIATRICS 1999 NASAL CPAP AND EARLY SURFACTANT MORTALITY

18 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS AT HIGH RISK OF AT HIGH RISK OF RESPIRATORY DISTRESS SYNDROME PROTOCOL

19 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS To 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 OBJECTIVE

20 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS The three approaches to post-delivery care: PS Group: Intubation, prophylactic surfactant administration PS Group: Intubation, prophylactic surfactant administration shortly after delivery, stabilization on ventilator support shortly after delivery, stabilization on ventilator support NCPAP Group: Early stabilization on nasal continuous positive NCPAP Group: Early stabilization on nasal continuous positive airway pressure (NCPAP) with selective intubation and airway pressure (NCPAP) with selective intubation and surfactant administration for clinical indications surfactant administration for clinical indications ISX Group: Intubation, prophylactic surfactant ISX Group: Intubation, prophylactic surfactant administration, and rapid extubation to Nasal CPAP administration, and rapid extubation to Nasal CPAP

21 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS : ENROLLMENT CRITERIA Eligibility: Admission to L & D high risk of preterm delivery at gestational age 26+0 to 29+6 weeks high risk of preterm delivery at gestational age 26+0 to 29+6 weeks Inclusion Criteria: delivery imminent delivery imminent no maternal rupture of membranes > 14 days no maternal rupture of membranes > 14 days no potentially life threatening congenital anomaly or genetic syndrome no potentially life threatening congenital anomaly or genetic syndrome no known lung maturity no known lung maturity antenatal steroid status known antenatal steroid status known written informed consent obtained (prior to delivery) written informed consent obtained (prior to delivery) Randomization: Prior to delivery Exclusion Criteria (s/p delivery): stillborn (apgar score of 0 at one minute) stillborn (apgar score of 0 at one minute) potentially life threatening congenital anomaly/genetic syndrome potentially life threatening congenital anomaly/genetic syndrome

22 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS multicenter randomized clinical trial conducted at participating Vermont Oxford Network Centers STUDY DESIGN

23 DELIVERY 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 supportIntubation, prophylactic surfactant administration, subsequent stabilization on ventilator support early stabilization on NCPAP and selective intubation and surfactant administration for clinical indicationsearly stabilization on NCPAP and selective intubation and surfactant administration for clinical indications intubation prophylactic surfactant administration and rapid extubation to NCPAP.intubation prophylactic surfactant administration and rapid extubation to NCPAP. After delivery infants who meet all criteria will be enrolled in the trial.

24 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS: TREATMENT GROUPS Intubation in the delivery room between five and fifteen minutes of lifeIntubation in the delivery room between five and fifteen minutes of life Surfactant treatment s/p intubationSurfactant treatment s/p intubation Mechanical ventilationMechanical ventilation Extubation at anytime after 6 hours of age based on predefined criteriaExtubation at anytime after 6 hours of age based on predefined criteria PROPHYLACTIC SURFACTANT ADMINISTRATION (PS GROUP)

25 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS: TREATMENT GROUPS Stabilization on standardized NCPAP system applied within five to fifteen minutes after deliveryStabilization on standardized NCPAP system applied within five to fifteen minutes after delivery Bubble CPAP system at 5 cm H 2 0Bubble CPAP system at 5 cm H 2 0 Predefined criteria for respiratory insufficiency requiring intubation and surfactant treatmentPredefined criteria for respiratory insufficiency requiring intubation and surfactant treatment EARLY APPLICATION OF NASAL CONTINUOUS POSITVE AIRWAY PRESSURE (NCPAP GROUP)

26 DELIVERY 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 lifeIntubation in the delivery room between five and fifteen minutes of life Surfactant treatment s/p intubationSurfactant treatment s/p intubation Rapid extubation to standardized nasal CPAP bubble system at 5 cm H 2 0Rapid extubation to standardized nasal CPAP bubble system at 5 cm H 2 0

27 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS Intubation based on clinical status:Intubation based on clinical status: –apnea –respiratory failure (PCO2 > 65 mmHg) –hypoxemia (supplemental oxygen > 40%-60% to maintain oxygen saturation > 86%-94%) –severe respiratory distress Surfactant treatment s/p intubationSurfactant treatment s/p intubation CRITERIA FOR SELECTIVE INTUBATION AND SURFACTANT TREATMENT

28 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS PRIMARY OUTCOME MEASURE: Chronic Lung Disease or Mortality at 36 weeks adjusted age Chronic lung disease is defined as documented requirement for supplemental oxygen or respiratory support. Documented oxygen requirement will be defined as the need for supplemental oxygen to maintain an oxygen saturation 88%.

29 DELIVERY 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 group Will re-evaluate based on results of pilot study

30 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS Number of infants receiving surfactant treatmentNumber of infants receiving surfactant treatment Number of surfactant dosesNumber of surfactant doses Postnatal steroidsPostnatal steroids Clinical status during first 28 days of lifeClinical status during first 28 days of life Clinical status at 36 & 40 weeks adjusted ageClinical status at 36 & 40 weeks adjusted age Days on assisted ventilationDays on assisted ventilation Days on NCPAPDays on NCPAP Days on supplemental oxygenDays on supplemental oxygen Growth, day 28 and dischargeGrowth, day 28 and discharge PneumothoraxPneumothorax Pulmonary hemorrhagePulmonary hemorrhage Patent ductus arteriosusPatent ductus arteriosus Necrotizing enterocolitisNecrotizing enterocolitis Intraventricular hemorrhageIntraventricular hemorrhage Steroids for chronic lung diseaseSteroids for chronic lung disease MortalityMortality Duration of hospitalizationDuration of hospitalization Other complications of prematurityOther complications of prematurity Health and developmental status at 2 years adjusted ageHealth and developmental status at 2 years adjusted age SECONDARY OUTCOME MEASURES:

31 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS STUDY TIMELINE Study to be conducted in three stages Stage 1: Introduction of Nasal CPAP in routine NICU practiceStage 1: Introduction of Nasal CPAP in routine NICU practice Stage 2: Pilot study of feasibility of delivery room interventionsStage 2: Pilot study of feasibility of delivery room interventions Stage 3: Formal enrollment of subjects in large pragmatic trialStage 3: Formal enrollment of subjects in large pragmatic trial

32 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS Stage 1: Introduction of Nasal CPAP in routine NICU practice Build bubble CPAP devicesBuild bubble CPAP devices Educate centers regarding use of bubble NCPAPEducate centers regarding use of bubble NCPAP Incorporate bubble NCPAP into daily routine of NICUIncorporate bubble NCPAP into daily routine of NICU Evaluate competence of centers in use of bubble CPAPEvaluate competence of centers in use of bubble CPAP February through April 2003February through April 2003

33 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS Stage 2: Pilot study of feasibility of delivery room interventions Educate centers regarding conduct of delivery room management trialEducate centers regarding conduct of delivery room management trial Pilot study of randomization to all three arms of studyPilot study of randomization to all three arms of study May through October 2003May through October 2003 Determine feasibility of launching large pragmatic trialDetermine feasibility of launching large pragmatic trial

34 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS Stage 3: Formal enrollment of subjects in large pragmatic trial In accordance with insights gained from feasibility studyIn accordance with insights gained from feasibility study January 2004January 2004

35 DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS Interested centers must identify a study team comprised of a neonatologist, nurse practitioner or nurse, and a respiratory therapistInterested centers must identify a study team comprised of a neonatologist, nurse practitioner or nurse, and a respiratory therapist Team must commit to participating in a standardized education and training programTeam must commit to participating in a standardized education and training program Team 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 studyTeam 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 NETWORK CENTER PARTICIPATION


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