Optimization of Oxygen Saturation Targets for Preterm Resuscitation in the Delivery Room: A Randomized Controlled Trial
Study ID: STU 062014-010
Study Design: a prospective randomized controlled trial of oX50 versus oX25 versus ox75 will be conducted at Parkland Hospital. Study Population: neonates with obstetric gestational age (Ga) of 24-28 weeks, born at Parkland Hospital, Dallas, TX outcomes: a. Primary outcome: * increase in oxidative balance ratio from baseline by 20%. Secondary outcomes: Resuscitation measures required and neonatal morbidities Study procedure: a prospective randomized controlled trial of optimal oxygen strategy will be conducted at Parkland Hospital. Screening procedure: a research nurse will screen and identify eligible mothers admitted to labor and delivery suites at Parkland hospital. We will obtain antenatal informed consent from mothers admitted to the oB service. a total of 75 neonates will be enrolled in the trial, 25 in each group. Study intervention and control group: The study intervention #1 is the ox25where resuscitation will be initiated at 30% o2 and target goal saturations will be the 25th percentile saturations observed in healthy term newborns.52 The study intervention #2 is the ox75 where resuscitation will be initiated at 30% o2 and target goal saturations will be the 75th percentile saturations observed in healthy term newborns. The control group will be resuscitated with the oX50 in which resuscitation will be initiated with 30% o2 and target goal saturations will be the approximated median Spo2 observed in healthy term newborns as per current nRP guidelines. Table 1 compare the transitional goal saturations that will be used in oX25, oX50 and ox75. For the first 6 minutes after birth, target ranges of different strategies are different. after 6 min, the target ranges are similar. Target saturations are an approximation of the percentile curves created by Dawson et al based on transitional saturation data of 306 healthy term neonates who did not receive any intervention other than warmth and stimulation.52 Randomization and allocation Procedure: assignment to the oX25, oX%) and oX75 group will use a 1:1:1 allocation ratio. The Biostatistician will use a blocked randomization schema, programmed using SaS Proc Plan (SaS version 9.2, SaS institute, Cary, nC, uSa). allocation will be concealed by serially numbered, sealed opaque envelopes that will be opened sequentially by the resuscitation team before delivery. Resuscitation management: The high-risk resuscitation team attends delivery of all neonates [Less Than] 35 wks Ga. Radical pulse oximeters (Masimo, irvine, Ca) will be set to maximal sensitivity with 2 seconds averaging. Randomization will be done before delivery by opening a sealed, opaque envelope. The probe will be placed on the pre-ductal hand within the first 30 seconds of life using previously described strategies to optimize time to reliable signal as per nRP 2011 guidelines.56,59,68 a neonatal transducer (invos Cerebral oximeter Monitor , Covidien, Mansfield, Massachusetts) will be attached to left fronto-pareital forehead to measure continuous near infrared spectroscopy (niRS) measurements.69 apart from the randomly assigned o2 strategy, resuscitation will follow 2011 nRP guidelines. Treatment failure will be defined as HR[Less Than] 60 bpm after 90 seconds of resuscitation. in this event, the o2 concentration will be increased to 100% as recommended by current nRP guidelines.56 once HR is stabilized, Fio2 will be reduced to meet the goal saturations of the assigned strategy. if pulse oximetry does not register stable values, resuscitation will be continued at the current Fio2 as long as HR [Greater Than] 100 bpm is maintained. if HR remains below 100 bpm, after making ventilation correcting steps, Fio2 can be increased by 10-20% based on clinician's judgement.
Inclusion and its Explanation 1. Neonates of obstetric gestational age 24-28 weeks: Desired study population. These neonates frequently require resuscitation in the delivery room, are exposed to oxygen and are vulnerable to oxidative damage. Gestational age < 24 weeks is excluded as it is common practice to offer discussion regarding limit of viability during antenatal counselling in these patients. 2. Inborn at Parkland Hospital, Dallas, Tx: Single center study: study site 3. Resuscitation team present to initiate resuscitation: If delivery occurs precipitously before resuscitation team is present , the oxygen strategy protocol cannot be implemented in the first few minutes after birth. As we expect major differences in oxygen exposure during the first 6 minutes of life, these neonates will be excluded.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- Vishal Subodhbhai Kapadia
AMERICAN ACADEMY OF PEDIATRICS