BACKGROUND: Platelet transfusions are given to preterm infants with severe thrombocytopenia aiming to prevent haemorrhage. The PlaNeT2/MATISSE trial revealed higher rates of mortality and/or major bleeding in preterm infants receiving prophylactic platelet transfusions at a platelet count threshold of 50 × 109/L compared to 25 × 109/L. The extent to which this evidence has been incorporated into clinical practice is unknown, thus we aimed to describe current neonatal platelet transfusion practices in Europe. METHODS: We performed a prospective observational study in 64 neonatal intensive care units across 22 European countries between September 2022 and August 2023. Outcome measures included observed transfusion prevalence rates (per country and overall, pooled using a random effects Poisson model), expected rates based on patient-mix (per country, estimated using logistic regression), cumulative incidence of receiving a transfusion by day 28 (with death and discharge considered as competing events), transfusion indications, volumes and infusion rates, platelet count triggers and increment, and adverse effects. FINDINGS: We included 1143 preterm infants, of whom 71 (6.2%, [71/1143]) collectively received 217 transfusions. Overall observed prevalence rate was 0.3 platelet transfusion days per 100 admission days. By day 28, 8.3% (95% CI: 5.5-11.1) of infants received a transfusion. Most transfusions were indicated for threshold (74.2%, [161/217]). Pre-transfusion platelet counts were above 25 × 109/L in 33.1% [53/160] of these transfusions. There was significant variability in volume and duration. INTERPRETATION: The restrictive threshold of 25 × 109/L is being integrated into clinical practice. Research is needed to explore existing variation and generate evidence for various aspects including optimal volumes and infusion rates. FUNDING: Sanquin, EBA, and ESPR.
- Klíčová slova
- Epidemiology, Europe, Neonatal intensive care unit, Neonatology, Platelet transfusion, Preterm infants, Thrombocytopenia,
- Publikační typ
- časopisecké články MeSH
IMPORTANCE: Red blood cell (RBC) transfusions are frequently administered to preterm infants born before 32 weeks of gestation in the neonatal intensive care unit (NICU). Two randomized clinical trials (Effects of Transfusion Thresholds on Neurocognitive Outcomes of Extremely Low-Birth-Weight Infants [ETTNO] and Transfusion of Prematures [TOP]) found that liberal RBC transfusion thresholds are nonsuperior to restrictive thresholds, but the extent to which these results have been integrated into clinical practice since publication in 2020 is unknown. OBJECTIVE: To describe neonatal RBC transfusion practice in Europe. DESIGN, SETTING, AND PARTICIPANTS: This international prospective observational cohort study collected data between September 1, 2022, and August 31, 2023, with a 6-week observation period per center, from 64 NICUs in 22 European countries. Participants included 1143 preterm infants born before 32 weeks of gestation. EXPOSURE: Admission to the NICU. MAIN OUTCOMES AND MEASURES: Study outcome measures included RBC transfusion prevalence rates, cumulative incidence, indications, pretransfusion hemoglobin (Hb) levels, volumes, and transfusion rates, Hb increment, and adverse effects of RBC transfusion. RESULTS: A total of 1143 preterm infants were included (641 male [56.1%]; median gestational age at birth, 28 weeks plus 2 days [IQR, 26 weeks plus 2 days to 30 weeks plus 2 days]; median birth weight, 1030 [IQR, 780-1350] g), of whom 396 received 1 or more RBC transfusions, totaling 903 transfusions. Overall RBC transfusion prevalence rate during postnatal days 1 to 28 was 3.4 transfusion days per 100 admission days, with considerable variation across countries, only partly explained by patient mix. By day 28, 36.5% (95% CI, 31.6%-41.5%) of infants had received at least 1 transfusion. Most transfusions were given based on a defined Hb threshold (748 [82.8%]). Hemoglobin levels before transfusions indicated for threshold were below the restrictive thresholds set by ETTNO in 324 of 729 transfusions (44.4%) and TOP in 265 of 729 (36.4%). Conversely, they were between restrictive and liberal thresholds in 352 (48.3%) and 409 (56.1%) transfusions, respectively, and above liberal thresholds in 53 (7.3%) and 55 (7.5%) transfusions, respectively. Most transfusions given based on threshold had volumes of 15 mL/kg (470 of 738 [63.7%]) and were administered over 3 hours (400 of 738 [54.2%]), but there was substantial variation in dose and duration. CONCLUSIONS AND RELEVANCE: In this cohort study of very preterm infants, most transfusions indicated for threshold were given for pretransfusion Hb levels above restrictive transfusion thresholds evaluated in recent trials. These results underline the need to optimize practices and for implementation research to support uptake of evidence.
- MeSH
- jednotky intenzivní péče o novorozence * statistika a číselné údaje MeSH
- lidé MeSH
- novorozenec nedonošený MeSH
- novorozenec MeSH
- prospektivní studie MeSH
- transfuze erytrocytů * statistika a číselné údaje metody MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- novorozenec MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- Geografické názvy
- Evropa MeSH
IMPORTANCE: Preterm newborns at risk of respiratory distress syndrome are supported with continuous positive airway pressure (CPAP). Many newborns worsen despite CPAP and are intubated for surfactant administration, an effective therapy for treatment of respiratory distress syndrome. Endotracheal intubation is associated with adverse effects. Pharyngeal administration of surfactant to preterm animals and humans has been reported as an alternative. OBJECTIVE: To assess whether giving prophylactic oropharyngeal surfactant to preterm newborns at birth would reduce the rate of intubation for respiratory failure. DESIGN, SETTING, AND PARTICIPANTS: This unblinded, parallel-group randomized clinical trial (Prophylactic Oropharyngeal Surfactant for Preterm Infants [POPART]) was conducted from December 17, 2017, to September 11, 2020, at 9 tertiary neonatal intensive care units in 6 European countries. Newborns born before 29 weeks of gestation without severe congenital anomalies, for whom intensive care was planned, were eligible for inclusion. The data were analyzed from July 27, 2022, to June 20, 2023. INTERVENTION: Newborns were randomly assigned to receive oropharyngeal surfactant at birth in addition to CPAP or CPAP alone. Randomization was stratified by center and gestational age (GA). MAIN OUTCOMES AND MEASURES: The primary outcome was intubation in the delivery room for bradycardia and/or apnea or in the neonatal intensive care unit for prespecified respiratory failure criteria within 120 hours of birth. Caregivers were not masked to group assignment. RESULTS: Among 251 participants (mean [SD] GA, 26 [1.5] weeks) who were well matched at study entry, 126 (69 [54.8%] male) with a mean (SD) birth weight of 858 (261) grams were assigned to the oropharyngeal surfactant group, and 125 (63 [50.4%] male) with a mean (SD) birth weight of 829 (253) grams were assigned to the control group. The proportion of newborns intubated within 120 hours was not different between the groups (80 [63.5%) in the oropharyngeal surfactant group and 81 [64.8%] in the control group; relative risk, 0.98 [95% CI, 0.81-1.18]). More newborns assigned to the oropharyngeal surfactant group were diagnosed with and treated for pneumothorax (21 [16.6%] vs 8 [6.4%]; P = .04). CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that administration of prophylactic oropharyngeal surfactant to newborns born before 29 weeks' GA did not reduce the rate of intubation in the first 120 hours of life. These findings suggest that administration of surfactant into the oropharynx immediately after birth in addition to CPAP should not be routinely used. TRIAL REGISTRATION: EudraCT: 2016-004198-41.
- MeSH
- kojenec MeSH
- lidé MeSH
- novorozenec nedonošený MeSH
- novorozenec MeSH
- orofarynx MeSH
- plicní surfaktanty * terapeutické užití MeSH
- porodní hmotnost MeSH
- povrchově aktivní látky MeSH
- respirační insuficience * farmakoterapie MeSH
- syndrom respirační tísně novorozenců * prevence a kontrola farmakoterapie MeSH
- trvalý přetlak v dýchacích cestách metody MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- mužské pohlaví MeSH
- novorozenec MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- komentáře MeSH
- Názvy látek
- plicní surfaktanty * MeSH
- povrchově aktivní látky MeSH
- MeSH
- indukovaný porod MeSH
- lidé MeSH
- porodní děj * MeSH
- těhotenství MeSH
- uterotonika * MeSH
- Check Tag
- lidé MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- úvodníky MeSH
- Názvy látek
- uterotonika * MeSH
BACKGROUND: The impact of the permissive hypotension approach in clinically well infants on regional cerebral oxygen saturation (rScO2) and autoregulatory capacity (CAR) remains unknown. METHODS: Prospective cohort study of blinded rScO2 measurements within a randomized controlled trial of management of hypotension (HIP trial) in extremely preterm infants. rScO2, mean arterial blood pressure, duration of cerebral hypoxia, and transfer function (TF) gain inversely proportional to CAR, were compared between hypotensive infants randomized to receive dopamine or placebo and between hypotensive and non-hypotensive infants, and related to early intraventricular hemorrhage or death. RESULTS: In 89 potentially eligible HIP trial patients with rScO2 measurements, the duration of cerebral hypoxia was significantly higher in 36 hypotensive compared to 53 non-hypotensive infants. In 29/36 hypotensive infants (mean GA 25 weeks, 69% males) receiving the study drug, no significant difference in rScO2 was observed after dopamine (n = 13) compared to placebo (n = 16). Duration of cerebral hypoxia was associated with early intraventricular hemorrhage or death. Calculated TF gain (n = 49/89) was significantly higher reflecting decreased CAR in 16 hypotensive compared to 33 non-hypotensive infants. CONCLUSIONS: Dopamine had no effect on rScO2 compared to placebo in hypotensive infants. Hypotension and cerebral hypoxia are associated with early intraventricular hemorrhage or death. IMPACT: Treatment of hypotension with dopamine in extremely preterm infants increases mean arterial blood pressure, but does not improve cerebral oxygenation. Hypotensive extremely preterm infants have increased duration of cerebral hypoxia and reduced cerebral autoregulatory capacity compared to non-hypotensive infants. Duration of cerebral hypoxia and hypotension are associated with early intraventricular hemorrhage or death in extremely preterm infants. Since systematic treatment of hypotension may not be associated with better outcomes, the diagnosis of cerebral hypoxia in hypotensive extremely preterm infants might guide treatment.
- MeSH
- arteriální tlak * účinky léků MeSH
- biologické markery krev MeSH
- časové faktory MeSH
- dopamin terapeutické užití MeSH
- gestační stáří MeSH
- homeostáza MeSH
- hypotenze krev farmakoterapie mortalita patofyziologie MeSH
- intraventrikulární krvácení do mozku mortalita patofyziologie MeSH
- kojenec MeSH
- kojenecká mortalita MeSH
- kyslík krev MeSH
- lidé MeSH
- mortalita v nemocnicích MeSH
- mozková hypoxie krev mortalita patofyziologie MeSH
- mozkový krevní oběh * MeSH
- novorozenci extrémně nezralí * MeSH
- prospektivní studie MeSH
- saturace kyslíkem * MeSH
- sympatomimetika terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Evropa MeSH
- Názvy látek
- biologické markery MeSH
- dopamin MeSH
- kyslík MeSH
- sympatomimetika MeSH
BACKGROUND: Peripherally inserted central catheters (PICCs) are used to administer parenteral nutrition (PN) in very low birth weight infants (VLBW; <1500 g). Clinicians try to optimize early nutrition but also minimize the risks associated with intravascular devices. The objective of this study was to examine the early nutrition impact of discontinuing PN at different enteral feed volumes in VLBW infants. METHODS: In this unmasked, multicenter, randomized controlled trial, patients were randomly assigned to PICC removal and PN discontinuation at an enteral feed volume of 100 mL/kg/day (intervention) or 140 mL/kg/day (control). Clinically stable VLBW infants with a PICC in situ who were receiving PN were eligible for inclusion. Infants with major congenital anomalies were excluded. A total of 139 patients were enrolled; 69 and 70 patients were randomized to the intervention and control groups, respectively. The primary outcome measure was the mean difference in time (days) to regain birth weight. RESULTS: The groups were well matched at study entry. Patients in the intervention group regained birth weight more slowly (mean difference 1.5 days CI: 0.3-2.7 days, P = 0.01). The mean difference in time to regain birth weight for infants <1000 g was 2.8 days (95% CI: 0.8-4.8 days, P = 0.008). CONCLUSIONS: In VLBW infants, early PICC removal at an enteral feed volume of 100 mL/kg/day compared with later removal at 140 mL/kg/day resulted in a significant delay in time to regain birth weight, and this delay was more pronounced in infants <1000 g.
- Klíčová slova
- PICC, enteral nutrition, parenteral nutrition, peripherally inserted central catheter, randomized controlled trial, regain birth weight, very low birth weight infant,
- MeSH
- enterální výživa MeSH
- hmotnostní přírůstek * MeSH
- katétrové infekce * etiologie prevence a kontrola MeSH
- lidé MeSH
- nemoci novorozenců * etiologie prevence a kontrola MeSH
- novorozenec nedonošený MeSH
- novorozenec s velmi nízkou porodní hmotností * MeSH
- novorozenec MeSH
- parenterální výživa škodlivé účinky MeSH
- periferní katetrizace MeSH
- porodní hmotnost * MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- novorozenec MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH