scholarly journals Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants. A protocol for the SafeBoosC phase III randomized clinical trial

2019 ◽  
Author(s):  
Mathias Hansen ◽  
Adelina Pellicer ◽  
Christian Gluud ◽  
Eugene Dempsey ◽  
Jonathan Mintzer ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Cerebral Oxygenation ◽  
Phase Iii ◽  
Control Group ◽  
Treatment As Usual ◽  
Risk Of Death ◽  
Opt Out ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Postmenstrual Age

Abstract Background Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC-III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants. Methods/Design SafeBoosC III is an investigator-initiated multinational randomized, pragmatic phase III clinical trial. It is open label, but parts will be conducted blinded to intervention. Inclusion criteria consists of infants born below 28 weeks postmenstrual age and parental informed consent (unless the site has is using ‘opt-out’ or deferred consent). Exclusion criteria consists of missing parental informed consent (or if ‘opt-out’ is used, lack of record that clinical staff have explained the trial and the ‘opt-out’ consent process to parents and/or a record in the infant’s clinical file of parents’ decision to opt-out); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 hours after birth. Participants will be randomized 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 hours of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. To detect a 22% relative risk difference between the experimental and control group, we intend to randomize a cohort of 1600 infant. Discussion Treatment guided by cerebral NIRS oximetry has the potential to decrease risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates.

scholarly journals Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants. A protocol for the SafeBoosC randomised clinical phase III trial

2019 ◽  
Author(s):  
Mathias Hansen ◽  
Adelina Pellicer ◽  
Christian Gluud ◽  
Eugene Dempsey ◽  
Jonathan Mintzer ◽  
...  
Keyword(s):  
Infrared Spectroscopy ◽  
Preterm Infants ◽  
Near Infrared ◽  
Control Group ◽  
Severe Brain Injury ◽  
Treatment As Usual ◽  
Opt Out ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Postmenstrual Age

Abstract Background: Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC-III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants. Methods/Design: SafeBoosC III is an investigator-initiated multinational randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using ‘opt-out’ or deferred consent). Exclusion criteria will be no parental informed consent (or if ‘opt-out’ is used, lack of record that clinical staff have explained the trial and the ‘opt-out’ consent process to parents and/or a record of parents’ decision to opt-out in the infants clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 hours after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 hours of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants. Discussion: Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates. Trial registration: ClinicalTrial.gov NCT03770741 (registered 10/12-2018), https://clinicaltrials.gov/ct2/show/NCT03770741?recrs=b&cond=cerebral+near+infrared+spectroscopy&rank=3

scholarly journals Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Mathias Lühr Hansen ◽  
Adelina Pellicer ◽  
Christian Gluud ◽  
Eugene Dempsey ◽  
Jonathan Mintzer ◽  
...  
Keyword(s):  
Infrared Spectroscopy ◽  
Preterm Infants ◽  
Near Infrared ◽  
Control Group ◽  
Severe Brain Injury ◽  
Treatment As Usual ◽  
Opt Out ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Postmenstrual Age

Abstract Background Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants. Methods/design SafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using ‘opt-out’ or deferred consent). Exclusion criteria will be no parental informed consent (or if ‘opt-out’ is used, lack of a record that clinical staff have explained the trial and the ‘opt-out’ consent process to parents and/or a record of the parents’ decision to opt-out in the infant’s clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants. Discussion Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates. Trial registration ClinicalTrial.gov, NCT03770741. Registered 10 December 2018.

Safety of Allogenic Human Cord Blood Derived Mononuclear Cells for Extreme Preterms Infants at High Risk of Death: A Descriptive Study

2020 ◽  
Author(s):  
Jia Chen ◽  
Yabo Mei ◽  
Xue Du ◽  
Qiuping Li ◽  
Zizhen Wang ◽  
...  
Keyword(s):  
High Risk ◽  
Cord Blood ◽  
Preterm Infants ◽  
Mononuclear Cells ◽  
Human Umbilical Cord ◽  
Risk Of Death ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Risk Potential

Abstract Backgroud Extreme preterm infants are at a high risk for developing preterm complications and death. Despite advances in medical care, many survivors face a lifetime of disability. Objective To assess the short term safety of and four-year follow-up outcomes of allogenic, human umbilical cord blood (hUCB) derived mononuclear cells(MNCs) infusion to extreme preterm infants with high risk potential of death. Method This study was a phase I, open-label, single-arm, single-center trial to evaluate the safety of allogenic, hUCB-MNCs infusion for extreme preterm infants with high risk potential of death. HUCB MNCs characteristics, pre- and postinfusion vital signs and laboratory investigations were recorded. Temporal profiles of cytokines and growth factors from blood were test. Clinical data including mortality rates, preterm complications and follow-up outcomes were recorded. Results After processing, relatively MNCs mean (1.9±0.8) ×106/kg; volume mean (11.25±2.12)ml/kg were infused to 10 extremely preterm infants with high risk of death. No adverse effects were noticed during treatment. 40% received extubation and weaned to nasal CPAP successfully; 30% received lower FiO2; no infants suffered from late onset sepsis; 30% received poor response to MNCs infusion. 40% infants suffered from ROP and only one infant needed laser surgery. No patients suffered from NEC after MNCs infusion. All ten infants who received hUCB MNCs infusion survived inhospital and prevent deterioration of clinical features, but 4 infants discharged against the advice of the doctor by their parents and lost connection. Regarding the rest 6 infants, no home oxygen therapy and rehospitalization, no suffered from other long-term respiratory complications at visit 1～visit 3. One infant showed cerebral palsy at visit 1, no clinical evidence associated this with MNCs infusion. Blood level of HGF significantly increased, but MMP-9, IL-6, IL-8, TNF-α and TGF-β levels were significantly lower at 24h post infusion compared with baseline (P < 0.05).Conclusions Collection, preparation, and infusion of allogenic hUCB MNCs to extreme preterm infants is feasible and safe. Trial registration The study was registered on Chinese Clinical Trials.gov (NO. ChiCTR–OPN - 15006932). Registered 17 August 2015, http://www.chictr.org.cn/edit.aspx?pid=11662&htm=4.

Do extremely preterm infants need retinopathy of prematurity screening earlier than 31 weeks postmenstrual age?

2020 ◽  
Author(s):  
Amy J. Sloane ◽  
Elizabeth A. O’Donnell ◽  
Amy B. Mackley ◽  
Julia E. Reid ◽  
Jay S. Greenspan ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Retinopathy Of Prematurity ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Postmenstrual Age

scholarly journals CEREBRAL OXYGENATION AND PERIPHERAL OXIMETRY IN EXTREMELY PRETERM INFANTS WITH PULMONARY AND/OR CEREBRAL INTRAVENTRICULAR HEMORRHAGE IN THE FIRST 72 HOURS OF LIFE

2018 ◽  
Vol 23 (suppl_1) ◽  
pp. e22-e23
Author(s):  
Thierry Beausoleil ◽  
Marie Janaillac ◽  
Keith Barrington ◽  
Marie-Josée Raboisson ◽  
Oliver Karam ◽  
...  
Keyword(s):  
Oxygen Saturation ◽  
Preterm Infants ◽  
Premature Infants ◽  
Cross Correlation ◽  
Cerebral Oxygenation ◽  
Invasive Monitoring ◽  
Time Frequency ◽  
Non Invasive ◽  
Extremely Preterm ◽  
Extremely Preterm Infants

Abstract BACKGROUND Extremely premature infants born <28 weeks of gestation are at higher risk of pulmonary (PH) and cerebral intraventricular (IVH) hemorrhage due to immature cardiovascular and transitioning physiology. Non-invasive monitoring has the potential to detect early abnormal circulation. OBJECTIVES To explore time-frequency relationships between cerebral oxygenation and peripheral oximetry. DESIGN/METHODS Near infrared spectroscopy cerebral regional haemoglobin oxygen saturation (CrSO2), preductal peripheral perfusion index (PI), heart rate (HR), capillary oxygen saturation (SpO2), and blood pressure (BP) were monitored in the first 72h of life. Patients were grouped in infants with PH and/or IVH (n=8) and controls (n=10). Signals were decomposed in wavelets allowing the analysis of localized variations of power. This approach allowed to quantify the common power and determine the duration of significant cross-correlation, phase and coherence between each pair of signals. Groups were compared with Wilcoxon tests. RESULTS Figure 1 shows an example of CrSO2 and PI, and their cross-correlation, phase (semblance) and coherence in a control (left column) and a PH-IVH patient (right column). Durations of significant cross-correlation between CrSO2 and HR (p<0.01), and CrSO2 and SpO2 (p=0.02) were significantly lower in PH-IVH infants compared to controls. The duration of significant anti-phase between CrSO2 and SpO2 (p=0.01) and the duration of significant coherence between PI and BP (p=0.03) were also significantly lower in PH-IVH infants compared to controls. These differences may indicate a disruption in auto-regulation, which is currently incompletely understood in this population. CONCLUSION This study is the first to apply time-frequency analysis to simultaneous NIRS and preductal peripheral oximetry in extremely preterm infants early in life. Significantly lower durations of cross-correlation (CrSO2 with HR and SpO2), anti-phase (CrSO2, SpO2) and coherence (PI, BP) in PH-IVH patients may reflect early abnormal circulation. Our results show the potential of non-invasive monitoring to identify premature infants at-risk of early PH-IVH.

scholarly journals Use of Intranasal Insulin as Neuroprotection From Hyperglycemia in Rat Model of Extremely Preterm Infants

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A444-A444
Author(s):  
Lauren McClure Yauch ◽  
Kathleen Ennis ◽  
Ivan Tkac ◽  
Raghavendra Rao
Keyword(s):  
Preterm Infants ◽  
Neuronal Activity ◽  
Rat Model ◽  
Control Group ◽  
Intranasal Insulin ◽  
Long Term Effects ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Neurochemical Profile

Abstract Background: Hyperglycemia is common in extremely preterm infants (EPI) and is a risk factor for increased mortality and morbidity, including abnormal neurodevelopment. Hippocampus-mediated cognitive deficits are common in this population. In a rat model of insulinopenic hyperglycemia, abnormal neurochemistry in the hippocampus was found, with lactate, glutamate (Glu):glutamine (Gln) ratio lower and Phosphorylated Creatinine (PCr):Creatinine (Cr) higher. Intranasal insulin has been shown to improve cognitive function in animal models of Alzheimer’s disease and type 2 diabetes mellitus, as well as in adult human studies of Alzheimer’s disease. No study has previous investigated the use of intranasal insulin on preventing the long-term effects of hyperglycemia in the EPI population. Objective: To determine whether administration of intranasal insulin during early postnatal days would negate the effects of hyperglycemia on the developing hippocampus in neonatal rat model of streptozotocin (STZ)-induced hyperglycemia. Design/Methods: STZ (80mg/kg IP) was injected on postnatal day (P) 2, and littermates in the control group were injected with an equivalent volume of citrate buffer. STZ pups were randomized to intranasal insulin, 3U twice daily from P3-P6 (STZ + INS) or left untreated (STZ). Neurochemical profile (consisting of 20 metabolites, PCr:Cr and Glu:Gln ratios) of the hippocampus was evaluated using ultra-high-field (9.4 T) magnetic resonance spectroscopy (MRS) on P7 (acute effects) and P56 (long-term effects) compared with the control group (CON)(N=6/group). Results: Mean glucose values from P3-P6 were higher in STZ groups (STZ = 279.0 +/- 132.2 mg/dL, STZ+INS = 274.4 +/- 89.5 mg/dL, CONT = 128.4 +/- 15.1 mg/dL). The neurochemical profile was different at both P7 and P56. On P7, compared with the control, the taurine (Tau) was higher in the STZ groups (p = 0.007. At P56, PCr:Cr was higher in the STZ group compared to CONT and STZ+INS groups (p = 0.04). No difference noted between the STZ+INS and CONT groups. No other metabolites were altered. Conclusion: Neonatal hyperglycemia alters the acute and long-term neurochemical profile in the hippocampus of developing rats. The increase in PCr:Cr ratio in the STZ group indicates lower demand for ATP and PCr, secondary to decreased neuronal activity, which has been demonstrated in previous studies. PCr:Cr ratio of the STZ+INS group was no different than control, indicating that intranasal insulin reverses the negative effect on neuronal activity caused by neonatal hyperglycemia.

scholarly journals Follow-Up Examination at the Age of 15 Months of Extremely Preterm Infants after Postnatal Estradiol and Progesterone Replacement

2001 ◽  
Vol 86 (2) ◽  
pp. 601-603 ◽  
Author(s):  
Andreas Trotter ◽  
Birgit Bokelmann ◽  
Wolfgang Sorgo ◽  
Doris Bechinger-Kornhuber ◽  
Hilde Heinemann ◽  
...  
Keyword(s):  
Pilot Study ◽  
Preterm Infants ◽  
Bone Mineralization ◽  
Psychomotor Development ◽  
Control Group ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Developmental Index ◽  
The Impact

A randomized controlled pilot study was performed with a sample of extremely preterm infants to evaluate the impact of postnatal estradiol and progesterone replacement on postnatal bone mineral accretion. Twenty-five of 30 infants in the pilot study survived, and of these, 24 infants were available for the follow-up examination at a median chronological age of 18.1 months (minimum-maximum, 17.0–20.6) corresponding to a corrected age of 14.8 months (minimum-maximum, 12.9–17.4). Somatic growth data and bone mineralization showed no differences between the hormone-treated and control group infants. The deviation of the skeletal age from the corrected age was 0.0 months (minimum-maximum, −7.7 to 7.4) for hormone-treated infants compared with −1.7 months (minimum-maximum, −7.5 to 5.9) for the control group. The Bayley scales mental and psychomotor developmental indexes were 89 (minimum-maximum, 71–107) and 101 (minimum-maximum, 49–121) for the hormone-treated infants and 93 (minimum-maximum, 49–111) and 71 (minimum-maximum, 49–121) for the control group infants, respectively (mental developmental index, P = 1.0; psychomotor developmental index, P = 0.14). The normal psychomotor development in the hormone-treated infants compared with the below average development in the control group infants is encouraging and indicates the potentially important integrative role of sex steroids for the developing brain. Larger studies on the effects of the postnatal replacement of estradiol and progesterone in extremely preterm infants are warranted.

scholarly journals When does prone sleeping improve cardiorespiratory status in preterm infants in the NICU?

SLEEP ◽  
2019 ◽  
Vol 43 (4) ◽  
Author(s):  
Kelsee L Shepherd ◽  
Stephanie R Yiallourou ◽  
Alexsandria Odoi ◽  
Emma Yeomans ◽  
Stacey Willis ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Respiratory Function ◽  
Sleep Position ◽  
Prone Positioning ◽  
Quiet Sleep ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Postmenstrual Age

Abstract Study Objectives Preterm infants undergoing intensive care are often placed prone to improve respiratory function. Current clinical guidelines recommend preterm infants are slept supine from 32 weeks’ postmenstrual age, regardless of gestational age at birth. However, respiratory function is also related to gestational and chronological ages and is affected by sleep state. We aimed to identify the optimal timing for adopting the supine sleeping position in preterm infants, using a longitudinal design assessing the effects of sleep position and state on cardiorespiratory stability. Methods Twenty-three extremely (24–28 weeks’ gestation) and 33 very preterm (29–34 weeks’ gestation) infants were studied weekly from birth until discharge, in both prone and supine positions, in quiet and active sleep determined by behavioral scoring. Bradycardia (heart rate ≤100 bpm), desaturation (oxygen saturation ≤80%), and apnea (pause in respiratory rate ≥10 s) episodes were analyzed. Results Prone positioning in extremely preterm infants reduced the frequency of bradycardias and desaturations and duration of desaturations. In very preterm infants, prone positioning only reduced the frequency of desaturations. The position-related effects were not related to postmenstrual age. Quiet sleep in both preterm groups was associated with fewer bradycardias and desaturations, and also reduced durations of bradycardia and desaturations in the very preterm group. Conclusions Cardiorespiratory stability is improved by the prone sleep position, predominantly in extremely preterm infants, and the improvements are not dependent on postmenstrual age. In very preterm infants, quiet sleep has a more marked effect than the prone position. This evidence should be considered in individualizing management of preterm infant positioning.

scholarly journals Early progressive feeding in extremely preterm infants: a randomized trial

2018 ◽  
Vol 107 (3) ◽  
pp. 365-370 ◽  
Author(s):  
Ariel A Salas ◽  
Peng Li ◽  
Kelli Parks ◽  
Charitharth V Lal ◽  
Camilia R Martin ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Enteral Feeding ◽  
Primary Outcome ◽  
Central Venous Access ◽  
Venous Access ◽  
Feeding Group ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Postmenstrual Age ◽  
Full Enteral Feeding

ABSTRACT Background Due to insufficient evidence, extremely preterm infants (≤28 wk of gestation) rarely receive early progressive feeding (small increments of feeding volumes between 1 and 4 d after birth). We hypothesized that early progressive feeding increases the number of full enteral feeding days in the first month after birth. Objective The aim of this study was to determine the feasibility and efficacy of early progressive feeding in extremely preterm infants. Design In this single-center randomized trial, extremely preterm infants born between September 2016 and June 2017 were randomly assigned to receive either early progressive feeding without trophic feeding (early feeding group) or delayed progressive feeding after a 4-d course of trophic feeding (delayed feeding group). Treatment allocation occurred before or on feeding day 1. The primary outcome was the number of full enteral feeding days in the first month after birth. Secondary outcomes were death, necrotizing enterocolitis (NEC), culture-proven sepsis, growth percentiles at 36 wk postmenstrual age, use of parenteral nutrition, and need for central venous access. Results Sixty infants were included (median gestational age: 26 wk; mean ± SD birth weight: 832 ± 253 g). The primary outcome differed between groups (median difference favoring the early feeding group: +2 d; 95% CI: 0, 3 d; P = 0.02). Early progressive feeding reduced the use of parenteral nutrition (4 compared with 8 d; P ≤ 0.01) and the need for central venous access (9 compared with 13 d; P ≤ 0.01). The outcome of culture-proven sepsis (10% compared with 27%; P = 0.18), restricted growth (weight, length, and head circumference <10th percentile) at 36 wk postmenstrual age (25% compared with 50%; P = 0.07), and the composite outcome of NEC or death (27% compared with 20%; P = 0.74) did not differ between groups. Conclusion Early progressive feeding increases the number of full enteral feeding days in extremely preterm infants. This trial was registered at www.clinicaltrials.gov as NCT02915549.

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