DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS AT HIGH RISK OF AT HIGH RISK OF RESPIRATORY DISTRESS...
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Transcript of DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTS AT HIGH RISK OF AT HIGH RISK OF RESPIRATORY DISTRESS...
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTSOF PREMATURE INFANTS
AT HIGH RISK OFAT HIGH RISK OFRESPIRATORY DISTRESS RESPIRATORY DISTRESS
SYNDROMESYNDROME
Vermont Oxford NetworkVermont Oxford Network
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTSOF PREMATURE INFANTS
STEERING COMMITTEESTEERING COMMITTEE
Jeanette M. Conner, PhD, MS Vermont Oxford NetworkJeanette M. Conner, PhD, MS Vermont Oxford NetworkAlan DeKlerk, MBChB, Maimonides Medical CenterAlan DeKlerk, MBChB, Maimonides Medical CenterRose DeKlerk RNC, New York Presbyterian Medical CenterRose DeKlerk RNC, New York Presbyterian Medical CenterMichael S. Dunn, MD, FRCPC, Sunnybrook & Women’s HospitalMichael S. Dunn, MD, FRCPC, Sunnybrook & Women’s HospitalJoseph Kaempf, MD, Providence St. Vincent Medical CenterJoseph Kaempf, MD, Providence St. Vincent Medical CenterMaureen Reilly, RRCP, NRCP, Sunnybrook & Women’s HospitalMaureen Reilly, RRCP, NRCP, Sunnybrook & Women’s HospitalRoger F. Soll, MD, Chair, Vermont Oxford NetworkRoger F. Soll, MD, Chair, Vermont Oxford Network EXPERT CONSULTANTEXPERT CONSULTANT
Jen-Tien Wung, MD, New York Presbyterian Medical CenterJen-Tien Wung, MD, New York Presbyterian Medical Center
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTSOF PREMATURE INFANTS
PATIENT SAFETY AND DATA COMMITTEEPATIENT SAFETY AND DATA COMMITTEE Steve Block, MD, ChairSteve Block, MD, ChairWake Forest University School of MedicineWake Forest University School of Medicine
Walter Ambrosius, PhDWalter Ambrosius, PhDWake Forest University School of MedicineWake Forest University School of Medicine
Arthur Kopelman, MDArthur Kopelman, MDEast Carolina UniversityEast Carolina University
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTSOF PREMATURE INFANTS
AT HIGH RISK OFAT HIGH RISK OFRESPIRATORY DISTRESS RESPIRATORY DISTRESS
SYNDROME:SYNDROME:
BACKGROUND and RATIONALEBACKGROUND and RATIONALE
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTSOF PREMATURE INFANTS
What is the best approach to take in the What is the best approach to take in the stabilization of premature infants at high risk of stabilization of premature infants at high risk of
developing respiratory distress syndrome?developing respiratory distress syndrome?
• delivery room intubation and prophylactic delivery room intubation and prophylactic surfactant surfactant administration with continued ventilator supportadministration with continued ventilator support
• delivery room intubation and prophylactic delivery room intubation and prophylactic surfactant surfactant administration without continued ventilator administration without continued ventilator supportsupport
• early stabilization on nasal continuous positiveearly stabilization on nasal continuous positive airway pressure (NCPAP)airway pressure (NCPAP)
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTS OF PREMATURE INFANTS
What is current practice regarding What is current practice regarding intubation and surfactant administration for intubation and surfactant administration for high risk infants (gestational age less than high risk infants (gestational age less than 30 weeks) in centers participating in the 30 weeks) in centers participating in the
Vermont Oxford Network?Vermont Oxford Network?
0%
20%
40%
60%
80%
100%
NO ETT
ETT
SURFACTANT
Gestational Age (weeks)
SURFACTANT TREATMENT AND ENDOTRACHEAL INTUBATION BY GESTATIONAL AGE
52,397 Infants 401 to 1500 Grams at 335 NICUS in 1998 and 1999
<24 24 25 26 27 28 29 30 31 32
>32
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTS OF PREMATURE INFANTS
What is the rationale for early or What is the rationale for early or prophylactic intubation and surfactant prophylactic intubation and surfactant
administration for high risk infants administration for high risk infants less than 30 weeks gestation?less than 30 weeks gestation?
PROPHYLACTIC SURFACTANT ADMINISTRATIONPROPHYLACTIC SURFACTANT ADMINISTRATION
• improved distributionimproved distribution• decreased barotraumadecreased barotrauma
• need for aggressiveneed for aggressive resuscitation practiceresuscitation practice• increased utilization/costincreased utilization/cost
ADVANTAGES:ADVANTAGES:
DISADVANTAGES:DISADVANTAGES:
Relative Risk and 95% CIRelative Risk and 95% CI
STUDYSTUDY0.50.5 1.01.0 2.02.0 4.04.00.20.2
DecreasedDecreased IncreasedIncreasedRiskRisk
0.50.5 1.01.0 2.02.0 4.04.00.20.2
PROPHYLACTIC vs. SELECTIVE SURFACTANTPROPHYLACTIC vs. SELECTIVE SURFACTANT
Dunn 1991Dunn 1991
EFFECT ON PNEUMOTHORAXEFFECT ON PNEUMOTHORAX
Egberts 1993Egberts 1993
Kattwinkel 1993Kattwinkel 1993
Walti 1995Walti 1995
Bevilacqua 1996Bevilacqua 1996
Soll 2001Soll 2001
TYPICAL ESTIMATETYPICAL ESTIMATE
Kendig 1991Kendig 1991
Relative Risk and 95% CIRelative Risk and 95% CI
STUDYSTUDY0.50.5 1.01.0 2.02.0 4.04.00.20.2
DecreasedDecreased IncreasedIncreasedRiskRisk
0.50.5 1.01.0 2.02.0 4.04.00.20.2
PROPHYLACTIC vs. SELECTIVE SURFACTANTPROPHYLACTIC vs. SELECTIVE SURFACTANT
Dunn 1991Dunn 1991
EFFECT ON NEONATAL MORTALITYEFFECT ON NEONATAL MORTALITY
Egberts 1993Egberts 1993
Kattwinkel 1993Kattwinkel 1993
Walti 1995Walti 1995
Bevilacqua 1996Bevilacqua 1996
Soll 2001Soll 2001
TYPICAL ESTIMATETYPICAL ESTIMATE
Kendig 1991Kendig 1991
Bevilacqua 1997Bevilacqua 1997
NASAL CONTINUOUS POSITIVE AIRWAY PRESSURENASAL CONTINUOUS POSITIVE AIRWAY PRESSURE
What about the early application ofWhat about the early application of
Nasal Continuous Positive Airway Pressure Nasal Continuous Positive Airway Pressure
(NCPAP)?(NCPAP)?
0%
10%
20%
30%
40%
50%
IMV SURF NEC CLD @ 28 CLD/DEATH
% I
NFA
NTS
1000
-149
9 g
BEFORE AFTER
De Klerk AM and De Klerk RK. J Paediatr Child Health 2001De Klerk AM and De Klerk RK. J Paediatr Child Health 2001
NASAL CPAP and OUTCOME OF PRETERM NASAL CPAP and OUTCOME OF PRETERM INFANTSINFANTS
Comparison of clinical outcome before (n=57) and after Comparison of clinical outcome before (n=57) and after (n=59) introduction of nasal continuous positive airway (n=59) introduction of nasal continuous positive airway
pressurepressure
Relative Risk and 95% CIRelative Risk and 95% CI
OUTCOME OUTCOME Risk DifferenceRisk Difference( 95% CI )( 95% CI ) 0.50.5 1.01.0 2.02.0 4.04.00.20.2
DecreasedDecreased IncreasedIncreasedRiskRisk
0.50.5 1.01.0 2.02.0 4.04.00.20.2
PROPHYLACTIC APPLICATION OF NASAL CPAPPROPHYLACTIC APPLICATION OF NASAL CPAP
RANDOMIZED CONTROLLED TRIAL OF 82 VLBW INFANTSRANDOMIZED CONTROLLED TRIAL OF 82 VLBW INFANTS(HAN AND COWORKERS 1987)(HAN AND COWORKERS 1987)
PNEUMOTHORAXPNEUMOTHORAX -0.01 (-0.14, 0.12)-0.01 (-0.14, 0.12)
SEPSISSEPSIS -0.04 (-0.21, 0.13)-0.04 (-0.21, 0.13)
IVHIVH
BRONCHOPULMONARY DYSPLASIABRONCHOPULMONARY DYSPLASIA 0.13 (-0.03, 0.29)0.13 (-0.03, 0.29)
MORTALITY MORTALITY 0.07 (-0.03, 0.17)0.07 (-0.03, 0.17)
USE OF IPPVUSE OF IPPV
NECROTIZING ENTEROCOLITISNECROTIZING ENTEROCOLITIS
0.09 (-0.12, 0.29)0.09 (-0.12, 0.29)
-0.14 (-0.30, 0.02)-0.14 (-0.30, 0.02)
0.15 (-0.02, 0.32)0.15 (-0.02, 0.32)
HAN 1987
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTS OF PREMATURE INFANTS
What is the rationale for considering What is the rationale for considering early or prophylactic intubation and early or prophylactic intubation and
surfactant administration followed by surfactant administration followed by rapid extubation and stabilization on rapid extubation and stabilization on
nasal CPAP?nasal CPAP?
0%
10%
20%
30%
40%
50%
60%
70%
MECHANICAL VENTILATION/MORTALITY
% C
AS
ES
EARLY TREATMENT LATE TREATMENT
VERDER H AND COWORKERS PEDIATRICS 1999VERDER H AND COWORKERS PEDIATRICS 1999
NASAL CPAP AND EARLY SURFACTANTNASAL CPAP AND EARLY SURFACTANT
MECHANICAL VENTILATION OR DEATHMECHANICAL VENTILATION OR DEATH
0%
10%
20%
30%
40%
MORTALITY
% C
AS
ES
EARLY TREATMENT LATE TREATMENT
VERDER H AND COWORKERS PEDIATRICS 1999VERDER H AND COWORKERS PEDIATRICS 1999
NASAL CPAP AND EARLY SURFACTANTNASAL CPAP AND EARLY SURFACTANT
MORTALITYMORTALITY
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTSOF PREMATURE INFANTS
AT HIGH RISK OFAT HIGH RISK OFRESPIRATORY DISTRESS RESPIRATORY DISTRESS
SYNDROMESYNDROME
PROTOCOLPROTOCOL
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTSOF PREMATURE INFANTS
To compare the effect of three distinct To compare the effect of three distinct methods of post-delivery stabilization methods of post-delivery stabilization and subsequent respiratory care on and subsequent respiratory care on chronic lung disease and survival in chronic lung disease and survival in premature infants at high risk of premature infants at high risk of respiratory distressrespiratory distress
OBJECTIVEOBJECTIVE
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTSOF PREMATURE INFANTS
The three approaches to post-delivery care:The three approaches to post-delivery care:
• PS Group: Intubation, prophylactic surfactant PS Group: Intubation, prophylactic surfactant administrationadministration shortly after delivery, stabilization on ventilator shortly after delivery, stabilization on ventilator supportsupport
• NCPAP Group: Early stabilization on nasal continuous NCPAP Group: Early stabilization on nasal continuous positivepositive airway pressure (NCPAP) with selective intubation airway pressure (NCPAP) with selective intubation andand surfactant administration for clinical indicationssurfactant administration for clinical indications
• ISX Group: ISX Group: Intubation, prophylactic surfactantIntubation, prophylactic surfactant administration, and rapid extubation to Nasal CPAPadministration, and rapid extubation to Nasal CPAP
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTS : ENROLLMENT CRITERIAOF PREMATURE INFANTS : ENROLLMENT CRITERIA
Eligibility: Admission to L & D Eligibility: Admission to L & D
• high risk of preterm delivery at gestational age 26+0 to 29+6 high risk of preterm delivery at gestational age 26+0 to 29+6 weeks weeks
Inclusion Criteria: Inclusion Criteria:
• delivery imminentdelivery imminent• no no maternal rupture of membranes > 14 daysmaternal rupture of membranes > 14 days• no potentially life threatening congenital anomaly or genetic no potentially life threatening congenital anomaly or genetic
syndromesyndrome • no known lung maturityno known lung maturity• antenatal steroid status knownantenatal steroid status known• written informed consent obtained (prior to delivery)written informed consent obtained (prior to delivery)
Randomization: Prior to deliveryRandomization: Prior to delivery
Exclusion Criteria (s/p 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 potentially life threatening congenital anomaly/genetic
syndromesyndrome
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTSOF PREMATURE INFANTS
multicenter randomized clinical multicenter randomized clinical trial conducted at participatingtrial conducted at participating
Vermont Oxford Network CentersVermont Oxford Network Centers
STUDY DESIGNSTUDY DESIGN
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTS : TREATMENT OF PREMATURE INFANTS : TREATMENT
GROUPSGROUPSEligible infants will have consent obtained prior to delivery.Eligible infants will have consent obtained prior to delivery.At imminent delivery premature infants will be randomized to either:At imminent delivery premature infants will be randomized to either:
• Intubation, prophylactic surfactant administration, subsequent Intubation, prophylactic surfactant administration, subsequent stabilization on ventilator supportstabilization on ventilator support
• early stabilization on NCPAP and selective intubation and early stabilization on NCPAP and selective intubation and surfactant administration for clinical indicationssurfactant administration for clinical indications
• intubation prophylactic surfactant administration and rapid intubation prophylactic surfactant administration and rapid extubation to NCPAP. extubation to NCPAP.
After delivery infants who meet all criteria will be enrolled in the After delivery infants who meet all criteria will be enrolled in the trial.trial.
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTS: TREATMENT OF PREMATURE INFANTS: TREATMENT
GROUPSGROUPS
• Intubation in the delivery room Intubation in the delivery room between five and fifteen minutes of between five and fifteen minutes of lifelife
• Surfactant treatment s/p intubationSurfactant treatment s/p intubation• Mechanical ventilationMechanical ventilation• Extubation at anytime after 6 hours Extubation at anytime after 6 hours
of age based on predefined criteriaof age based on predefined criteria
PROPHYLACTIC SURFACTANT ADMINISTRATION PROPHYLACTIC SURFACTANT ADMINISTRATION (PS GROUP)(PS GROUP)
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTS: TREATMENT GROUPSOF PREMATURE INFANTS: TREATMENT GROUPS
• Stabilization on standardized NCPAP system Stabilization on standardized NCPAP system applied within five to fifteen minutes after deliveryapplied within five to fifteen minutes after delivery
• Bubble CPAP system at 5 cm HBubble CPAP system at 5 cm H2200• Predefined criteria for respiratory insufficiency Predefined criteria for respiratory insufficiency
requiring intubation and surfactant treatmentrequiring intubation and surfactant treatment
EARLY APPLICATION OFEARLY APPLICATION OFNASAL CONTINUOUS POSITVE AIRWAY PRESSURE NASAL CONTINUOUS POSITVE AIRWAY PRESSURE
(NCPAP GROUP)(NCPAP GROUP)
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTS: TREATMENT OF PREMATURE INFANTS: TREATMENT
GROUPSGROUPS
PROPHYLACTIC SURFACTANT ADMINISTRATION,PROPHYLACTIC SURFACTANT ADMINISTRATION,RAPID EXTUBATION TO NASAL CONTINUOUS RAPID EXTUBATION TO NASAL CONTINUOUS
POSITVE AIRWAY PRESSURE POSITVE AIRWAY PRESSURE (ISX GROUP)(ISX GROUP)
• Intubation in the delivery room between five Intubation in the delivery room between five and fifteen minutes of lifeand fifteen minutes of life
• Surfactant treatment s/p intubationSurfactant treatment s/p intubation• Rapid extubation to standardized nasal CPAP Rapid extubation to standardized nasal CPAP
bubble system at 5 cm Hbubble system at 5 cm H2200
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTSOF PREMATURE INFANTS
• Intubation based on clinical status:Intubation based on clinical status:– apneaapnea– respiratory failure (PCO2 > 65 mmHg)respiratory failure (PCO2 > 65 mmHg)– hypoxemia (supplemental oxygen > 40%-hypoxemia (supplemental oxygen > 40%-
60%60%to maintain oxygen saturation > 86%-94%)to maintain oxygen saturation > 86%-94%)
– severe respiratory distresssevere respiratory distress• Surfactant treatment s/p intubationSurfactant treatment s/p intubation
CRITERIA FOR SELECTIVE INTUBATIONCRITERIA FOR SELECTIVE INTUBATIONAND SURFACTANT TREATMENTAND SURFACTANT TREATMENT
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTSOF PREMATURE INFANTS
PRIMARY OUTCOME MEASURE:
Chronic Lung Disease or Mortalityat 36 weeks adjusted age
Chronic 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%.
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTSOF 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
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTSOF PREMATURE INFANTS
• Number of infants receiving Number of infants receiving surfactant treatmentsurfactant treatment
• Number of surfactant dosesNumber of surfactant doses• Postnatal steroidsPostnatal steroids• Clinical status during first 28 Clinical status during first 28
days of lifedays of life• Clinical status at 36 & 40 Clinical status at 36 & 40
weeks adjusted ageweeks adjusted age• Days on assisted ventilationDays on assisted ventilation• Days on NCPAP Days 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 Steroids for chronic lung
diseasedisease• Mortality Mortality • Duration of hospitalizationDuration of hospitalization• Other complications of Other complications of
prematurityprematurity• Health and developmental Health and developmental
status at 2 years adjusted agestatus at 2 years adjusted age
SECONDARY OUTCOME MEASURES:SECONDARY OUTCOME MEASURES:
DELIVERY ROOM MANAGEMENT OF DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTSPREMATURE INFANTS
STUDY TIMELINESTUDY TIMELINE
Study to be conducted in three stagesStudy to be conducted in three stages
• Stage 1: Introduction of Nasal CPAP in routine NICU Stage 1: Introduction of Nasal CPAP in routine NICU practice practice
• Stage 2: Pilot study of feasibility of delivery room Stage 2: Pilot study of feasibility of delivery room interventionsinterventions
• Stage 3: Formal enrollment of subjects in large Stage 3: Formal enrollment of subjects in large pragmatic trialpragmatic trial
DELIVERY ROOM MANAGEMENT OF DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTSPREMATURE INFANTS
Stage 1: Introduction of Nasal CPAP in routine NICU Stage 1: Introduction of Nasal CPAP in routine NICU practicepractice
• 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 Evaluate competence of centers in use of bubble
CPAPCPAP• February through April 2003 February through April 2003
DELIVERY ROOM MANAGEMENT OF DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTSPREMATURE INFANTS
Stage 2: Pilot study of feasibility of delivery room Stage 2: Pilot study of feasibility of delivery room interventionsinterventions
• Educate centers regarding conduct of delivery room Educate centers regarding conduct of delivery room management trialmanagement 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
DELIVERY ROOM MANAGEMENT OF DELIVERY ROOM MANAGEMENT OF PREMATURE INFANTSPREMATURE INFANTS
Stage 3: Formal enrollment of subjects in large Stage 3: Formal enrollment of subjects in large pragmatic trialpragmatic trial
• In accordance with insights gained from feasibility In accordance with insights gained from feasibility studystudy
• January 2004January 2004
DELIVERY ROOM MANAGEMENTDELIVERY ROOM MANAGEMENTOF PREMATURE INFANTSOF PREMATURE INFANTS
• Interested centers must identify a study team Interested centers must identify a study team comprised of a neonatologist, nurse comprised of a neonatologist, nurse practitioner or nurse, and a respiratory practitioner or nurse, and a respiratory therapisttherapist
• Team must commit to participating in a Team must commit to participating in a standardized education and training programstandardized education and training program
• Team must implement education and training Team must implement education and training program within their NICU and unit must program within their NICU and unit must establish a level of competency with the establish a level of competency with the bubble CPAP system prior to initiating bubble CPAP system prior to initiating enrollment in pilot studyenrollment in pilot study
NETWORK CENTER PARTICIPATIONNETWORK CENTER PARTICIPATION