Aspirin Does Not Increase the Need for Hemostatic Interventions in Blunt Liver and Spleen Injuries.

Abstract Background: The prohemorrhagic effect of aspirin may cause concern about worse prognoses when treating blunt hepatic or splenic injuries. This study investigated whether preinjury aspirin yields an increasing need for hemostatic interventions.Methods: Admission and outpatient records were extracted from the Taiwan National Health Insurance Research Database (NHIRD) from 2003 to 2015. Patients with splenic or hepatic injuries were identified. Patients with preinjury nonaspirin APAC or with penetrating injuries were excluded. The primary outcome measurement was the necessity of invasive procedures to stop bleeding, including transarterial embolization (TAE) and surgeries. One-to-two propensity score matching (PSM) was used to minimize selection bias. Multilogistic regression (MLR) analysis was used to identify factors associated with hemostatic interventions.Results: 20,470 (60.6%) had blunt hepatic injuries, and 15,235 (45.1%) had blunt splenic injuries, of whom 691 (3.4%) and 667 (4.4%) used preinjury aspirin, respectively. In the blunt hepatic injury cohort, there was no significant difference in the need for hemostatic procedures (TAE (6.1% vs 6.1%, p=1.000), exploratory laparotomy (6.1% vs 6.1%, p=1.000), hepatectomy (3.0% vs 2.7%, p=0.694) or hepatorrhaphy (14.3% vs 15.0%, p=0.681)). MLR analysis showed that preinjury aspirin did not increase the need for hemostatic interventions (OR 0.92, 95% CI 0.73-1.16, p=0.473). Regarding the blunt splenic injury cohort, there was no significant difference in the need for hemostatic procedures (TAE (11.5% vs 10.6%, p=0.547), splenectomy (43.5% vs 41.4%, p=0.407) or splenorrhaphy (3.0% vs 3.3%, p=0.698)). An MLR analysis showed that preinjury aspirin did not increase the need for hemostatic interventions (OR 1.12, 95% CI 0.91-1.38, p=0.290).Conclusions: Preinjury aspirin use is not associated with increased hemostatic procedures in blunt hepatic or splenic injuries.

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The implications of catheter ablation for solitary atrial flutter in preventing stroke risk: a nationwide population-based cohort study

EP Europace ◽

10.1093/europace/euaa164 ◽

2020 ◽

Vol 22 (10) ◽

pp. 1558-1566

Author(s):

Yu-Sheng Lin ◽

Victor Chien-Chia Wu ◽

Hui-Ting Wang ◽

Huang-Chung Chen ◽

Mien-Cheng Chen ◽

...

Keyword(s):

Atrial Flutter ◽

Primary Outcome ◽

Stroke Risk ◽

Population Based ◽

Research Database ◽

Confounding Factors ◽

Subdistribution Hazard ◽

Taiwan National Health Insurance ◽

History Of

Abstract Aims The implications of ablation for atrial fibrillation in preventing stroke are controversial, and no studies have investigated whether ablation prevents ischaemic stroke (IS) in atrial flutter (AFL). Methods and results This study analysed data contained in the Taiwan National Health Insurance Research Database for 16 765 patients with a first diagnosis of solitary AFL during 2001–2013. Eligible patients were divided into two groups according to whether or not they had received ablation. Propensity score matching (PSM) was performed to mitigate the effects of potential confounding factors. The primary outcome was occurrence of IS during follow-up. After 1:2 PSM, the analysis included 1037 patients in the ablation group and 2074 patients in the non-ablation group. The incidence of IS was lower in the ablation group compared to the non-ablation group [subdistribution hazard ratio (SHR) 0.61, 95% confidence interval (CI) 0.41–0.90] during the 2-year follow-up period but not thereafter (SHR 1.03, 95% CI 0.72–1.48). When grouping by stroke history, it revealed that ablation affected the incidence of stroke in patients without history of stroke (SHR 0.59, 95% CI 0.38–0.91) but not in patients with history of stroke. When each group was stratified by CHA2DS2-VASc score, ablation lowered the incidence of stroke in patients with CHA2DS2-VASc ≤3 (SHR 0.31, 95% CI 0.16–0.60) but not in patients with CHA2DS2-VASc ≥4 in the initial 2-year follow-up. Conclusion The different incidence of IS in patients with/without ablation indicates that ablation reduces the risk of IS in AFL patients.

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Intracameral Bevacizumab Versus Sub-Tenon’s Mitomycin C as Adjuncts to Trabeculectomy: 3-Year Results of a Prospective Randomized Study

Journal of Clinical Medicine ◽

10.3390/jcm10102054 ◽

2021 ◽

Vol 10 (10) ◽

pp. 2054

Author(s):

Gerasimos Kopsinis ◽

Dimitrios Tsoukanas ◽

Dimitra Kopsini ◽

Theodoros Filippopoulos

Keyword(s):

Mitomycin C ◽

Primary Outcome ◽

Randomized Study ◽

Primary Outcome Measure ◽

Complication Rates ◽

Filtration Surgery ◽

Significant Difference ◽

Exfoliative Glaucoma

Conjunctival wound healing determines success after filtration surgery and the quest for better antifibrotic agents remains active. This study compares intracameral bevacizumab to sub-Tenon’s mitomycin C (MMC) in trabeculectomy. Primary open-angle or exfoliative glaucoma patients were randomized to either bevacizumab (n = 50 eyes) or MMC (n = 50 eyes). The primary outcome measure was complete success, defined as Intraocular Pressure (IOP) > 5 mmHg and ≤ 21 mmHg with a minimum 20% reduction from baseline without medications. Average IOP and glaucoma medications decreased significantly in both groups at all follow-up points compared to baseline (p < 0.001), without significant difference between groups at 3 years (IOP: bevacizumab group from 29 ± 9.4 to 15 ± 3.4 mmHg, MMC group from 28.3 ± 8.7 to 15.4 ± 3.8 mmHg, p = 0.60; Medications: bevacizumab group from 3.5 ± 0.9 to 0.5 ± 1, MMC group from 3.6 ± 0.7 to 0.6 ± 1.1, p = 0.70). Complete success, although similar between groups at 3 years (66% vs. 64%), was significantly higher for bevacizumab at months 6 and 12 (96% vs. 82%, p = 0.03; 88% vs. 72%, p = 0.04, respectively) with fewer patients requiring medications at months 6, 9 and 12 (4% vs. 18%, p = 0.03; 6% vs. 20%, p = 0.04; 8% vs. 24%, p = 0.03, respectively). Complication rates were similar between groups. In conclusion, intracameral bevacizumab appears to provide similar long-term efficacy and safety results as sub-Tenon’s MMC after trabeculectomy.

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Veno-arterial extracorporeal membrane oxygenation with concomitant Impella versus concomitant intra-aortic-balloon-pump for cardiogenic shock

Perfusion ◽

10.1177/02676591211033947 ◽

2021 ◽

pp. 026765912110339

Author(s):

Shek-yin Au ◽

Ka-man Fong ◽

Chun-Fung Sunny Tsang ◽

Ka-Chun Alan Chan ◽

Chi Yuen Wong ◽

...

Keyword(s):

Extracorporeal Membrane Oxygenation ◽

Mechanical Circulatory Support ◽

Primary Outcome ◽

Left Ventricular ◽

Circulatory Support ◽

Queen Elizabeth Hospital ◽

Intra Aortic Balloon Pump ◽

Membrane Oxygenation ◽

Significant Difference ◽

Va Ecmo

Introduction: The intra-aortic balloon pump (IABP) and Impella are left ventricular unloading devices with peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO) in place and later serve as bridging therapy when VA-ECMO is terminated. We aimed to determine the potential differences in clinical outcomes and rate of complications between the two combinations of mechanical circulatory support. Methods: This was a retrospective, single institutional cohort study conducted in the intensive care unit (ICU) of Queen Elizabeth Hospital, Hong Kong. Inclusion criteria included all patients aged ⩾18 years, who had VA-ECMO support, and who had left ventricular unloading by either IABP or Impella between January 1, 2018 and October 31, 2020. Patients <18 years old, with central VA-ECMO, who did not require left ventricular unloading, or who underwent surgical venting procedures were excluded. The primary outcome was ECMO duration. Secondary outcomes included length of stay (LOS) in the ICU, hospital LOS, mortality, and complication rate. Results: Fifty-two patients with ECMO + IABP and 14 patients with ECMO + Impella were recruited. No statistically significant difference was observed in terms of ECMO duration (2.5 vs 4.6 days, p = 0.147), ICU LOS (7.7 vs 10.8 days, p = 0.367), and hospital LOS (14.8 vs 16.5 days, p = 0.556) between the two groups. No statistically significant difference was observed in the ECMO, ICU, and hospital mortalities between the two groups. Specific complications related to the ECMO and Impella combination were also noted. Conclusions: Impella was not shown to offer a statistically significant clinical benefit compared with IABP in conjunction with ECMO. Clinicians should be aware of the specific complications of using Impella.

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INR Response to Low-Dose Vitamin K in Warfarin Patients

Annals of Pharmacotherapy ◽

10.1177/1060028021993239 ◽

2021 ◽

pp. 106002802199323

Author(s):

Caitlin E. Kulig ◽

A. Joshua Roberts ◽

A. Shaun Rowe ◽

Hahyoon Kim ◽

William E. Dager

Keyword(s):

Vitamin K ◽

Primary Outcome ◽

Low Dose ◽

International Normalized Ratio ◽

Mortality Rates ◽

Observational Cohort Study ◽

Significant Difference ◽

Observational Cohort ◽

Reduction Effect ◽

Retrospective Observational Cohort Study

Background Literature suggests that 2 mg of vitamin K intravenously (IV) provides a similar effect as 10 mg to reverse warfarin. Doses <5 mg haven’t been studied in depth. Objective The objective was to determine the international normalized ratio (INR) reduction effect of ultra low-dose (ULD) IV vitamin K. Methods This retrospective, observational cohort study compared IV vitamin K doses of 0.25-0.5 mg (ULD) versus 1-2 mg (standard low dose [SLD]). The primary outcome assessed ΔINR at 36 hours; secondary outcomes assessed ΔINR at 12 hours and 30-day venous thromboembolism (VTE) and mortality rates. Results Of 88 patients identified (median baseline INR [IQR], 5.1 [3.1, 7.3] vs 4.5 [2.8, 8.2], ULD vs SLD, respectively), 59 had an INR at 12 hours. The ULD had fewer 12-hour INR values <2, with no statistical difference in the ΔINR at 12 hours between the ULD and SLD cohorts (median ΔINR, 2.2 [1.1, 3.4] vs 2.2 [1.1, 6.3]; P = 0.54; median INR, 2.3 vs 1.8). A total of 41 patients had both a 12- and 36-hour INR. No significant difference in the ΔINR between the 12- and 36-hour values occurred (median ΔINR, 0.52 [0.2, 0.91] vs ΔINR, 0.46 [0.18, 0.55]; P = 0.61), suggesting no rebound or excessive reversal and no difference in 30-day rates of VTE ( P > 0.99) or death ( P = 0.38). Conclusion and Relevance ULD IV vitamin K reversed INR similarly to doses of 1-2 mg without rebound. A ULD strategy may be considered in patients requiring more cautious reversal.

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Comparison of Simulation-Based versus Cadaveric-Tissue-Based Ocular Trauma Training on Novice Ophthalmologists: Repair of Corneal Laceration Model

Journal of Academic Ophthalmology ◽

10.1055/s-0041-1725093 ◽

2021 ◽

Vol 13 (01) ◽

pp. e57-e65

Author(s):

Boonkit Purt ◽

Timothy Ducey ◽

Sean Sykes ◽

Joseph F. Pasternak ◽

Denise S. Ryan ◽

...

Keyword(s):

Primary Outcome ◽

Wound Closure ◽

Ocular Trauma ◽

Controlled Trial ◽

Preliminary Evaluation ◽

Skills Acquisition ◽

Visual Axis ◽

Significant Difference ◽

Skills Laboratory ◽

Corneal Laceration

Abstract Purpose The aim of this study was to evaluate whether the simulated tissue models may be used in place of animal-based model for corneal laceration repair for surgical skills acquisition. Design Prospective randomized controlled trial. Participants Seventy-nine military and civilian 2nd- and 3rd-year ophthalmology residents and 16 staff ophthalmologists participating in the Tri-Service Ocular Trauma Skills Laboratory at the Uniformed Services University (Bethesda, MD). Methods Resident ophthalmologists underwent preliminary evaluation of their ability to close a 5-mm linear, full-thickness corneal laceration involving the visual axis. They then were randomized to undergo 90 to 120 minutes of either simulator-based (SIM) or swine cadaveric-tissue-based (CADAVER) corneal laceration repair. The same evaluation was performed post training. On a more limited basis, the study was repeated for attending ophthalmologists to act as a pilot for future analysis and test efficacy for “refresher” training. Main Outcome Measures Successful wound closure with secondary outcomes of suture length, tension, depth, and orientation, as graded by attending ophthalmologists. Results No significant difference in CADAVER versus SIM groups in the primary outcome of watertight wound closure of the corneal laceration. CADAVER group performed better than SIM group for certain metrics (suture depth, p = 0.009; length, p = 0.003; and tension, p = 0.043) that are associated with poor wound closure and increased amount of induced corneal astigmatism. For attending ophthalmologists, six of the eight in each group (SIM and CADAVER) retained or improved their skills. Conclusions For resident ophthalmologists, SIM training is sufficient for achieving the primary outcome of watertight wound closure. However, CADAVER training is superior for wound metrics for the ideal closure. For attending ophthalmologists, SIM training may be useful for retention of skills.

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Risk of herpes zoster in psoriasis patients receiving systemic therapies: a nationwide population-based cohort study

Scientific Reports ◽

10.1038/s41598-021-91356-3 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Sze-Wen Ting ◽

Sze-Ya Ting ◽

Yu-Sheng Lin ◽

Ming-Shyan Lin ◽

George Kuo

Keyword(s):

Cohort Study ◽

Herpes Zoster ◽

Population Based ◽

Research Database ◽

Newly Diagnosed ◽

Increased Risk ◽

Taiwan National Health Insurance ◽

Reduced Risk ◽

Systemic Therapies

AbstractThe incidence of herpes zoster in psoriasis patients is higher than in the general population. However, the association between herpes zoster risk and different systemic therapies, especially biologic agents, remains controversial. This study investigated the association between herpes zoster risk and several systemic antipsoriasis therapies. This prospective open cohort study was conducted using retrospectively collected data from the Taiwan National Health Insurance Research Database. We included 92,374 patients with newly diagnosed psoriasis between January 1, 2001, and December 31, 2013. The exposure of interest was the “on-treatment” effect of systemic antipsoriasis therapies documented by each person-quarter. The outcome was the occurrence of newly diagnosed herpes zoster. During a mean follow-up of 6.8 years, 4834 (5.2%) patients were diagnosed with herpes zoster after the index date. Among the systemic antipsoriasis therapies, etanercept (hazard ratio [HR] 4.78, 95% confidence interval [CI] 1.51–15.17), adalimumab (HR 5.52, 95% CI 1.72–17.71), and methotrexate plus azathioprine (HR 4.17, 95% CI 1.78–9.82) were significantly associated with an increased risk of herpes zoster. By contrast, phototherapy (HR 0.76, 95% CI 0.60–0.96) and acitretin (HR 0.39, 95% CI 0.24–0.64) were associated with a reduced risk of herpes zoster. Overall, this study identified an association of both etanercept and adalimumab with an increased risk of herpes zoster among psoriasis patients. Acitretin and phototherapy were associated with a reduced risk.

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1611. Evaluating Clinical Outcomes and Efficacy of Daptomycin in Combination with a Beta-Lactam for the Treatment of Vancomycin-Resistant Enterococcus (VRE) Bacteremia

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.1791 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S799-S800

Author(s):

Nerea Irusta ◽

Ana Vega ◽

Yoichiro Natori ◽

Lilian M Abbo ◽

...

Keyword(s):

Clinical Outcomes ◽

Primary Outcome ◽

Small Sample Size ◽

Univariate Analysis ◽

Small Sample ◽

Significant Difference ◽

Vancomycin Resistant ◽

Secondary Outcomes ◽

Related Mortality

Abstract Background In-vitro studies have shown synergistic bactericidal activity with daptomycin (DAP) plus β-lactam antimicrobials against vancomycin resistant enterococci (VRE). There is a paucity of data regarding clinical outcomes with this combination in VRE bloodstream infections (BSI). The purpose of this study was to assess the efficacy of DAP plus a β-lactam with in-vitro activity vs. other therapies for treatment of VRE BSI. Methods IRB-approved, single-center, retrospective study of patients with VRE BSI from 01/2018-09/2019. Patients were excluded if < 18 years old, pregnant, or incarcerated. The primary outcome was time-to-microbiological clearance. Secondary outcomes included infection-related mortality, 30-day all-cause mortality, and incidence of recurrent BSI within 30 days of index culture. Targeted DAP doses were ≥ 8mg/kg and based on MIC. Factors associated with significance for outcomes, via univariate analysis, were evaluated with multivariable logistic regression (MLR), removed in a backward-step approach. Results A total of 85 patients were included, 23 of which received DAP plus a β-lactam. The comparator arm included linezolid or DAP monotherapy. Patients with combination therapy had significantly higher Charlson Comorbidity Index (CCI) (p=0.013) and numerically higher Pitt Bacteremia scores (PBS) (p=0.087) (Table 1). There was no difference seen in the primary outcome (Table 2). Secondary outcomes are provided in Table 2. The presence of polymicrobial infection and higher PBS were significantly associated with infection-related mortality (p=0.008 and p=0.005, respectively) by MLR. A Mann Whitney U test indicated that presence of infection-related mortality was greater for patients with higher MICS (U=20.5, p=0.06). The presence of an underlying source may be related to recurrence of BSI (p=0.075). Table 1: Patient Characteristics Table 2. Primary and Secondary Outcomes Conclusion We did not find a significant difference in time-to-microbiological clearance, although patients treated with DAP and a β-lactam had higher CCI and PBS. These results are limited by retrospective design, small sample size, and potential selection bias. Prospective randomized studies are needed to further validate these findings. Disclosures All Authors: No reported disclosures

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The Risk of Developing Osteoporosis in Hemolytic Anemia—What Aggravates the Bone Loss?

Journal of Clinical Medicine ◽

10.3390/jcm10153364 ◽

2021 ◽

Vol 10 (15) ◽

pp. 3364

Author(s):

Leiyu Shi ◽

Cheng-Li Lin ◽

Ching-Huang Su ◽

Keng-Chian Lin ◽

Kam-Hang Leong ◽

...

Keyword(s):

Hemolytic Anemia ◽

Nuclear Factor Κb ◽

Incidence Density ◽

Rank Test ◽

Research Database ◽

Best Interest ◽

Ulcer Disease ◽

Preventative Measures ◽

Related Transcription Factor ◽

Taiwan National Health Insurance

Hemolytic anemia (HA) renders erythropoietic stress on the bone marrow and has been linked to osteoporosis. In this nationwide retrospective cohort study, we examined this correlation by utilizing the Taiwan National Health Insurance Research Database (NHIRD). We identified two cohorts, matching population with and without HA in a 1:4 ratio. A total of 2242 HA patients and 8968 non-HA patients were enrolled. Patients with HA had a significantly higher cumulative incidence (log-rank test p = 0.0073), higher incidence density (5.11 vs. 3.76 per 1000 persons-years), and a 1.31-fold risk of developing osteoporosis than non-HA patients (aHR = 1.31, 95% C.I. 1.04–1.63, p = 0.01). After adjusting for age, sex, and comorbidities, patients with factors including female (aHR = 2.57, 95% C.I. 2.05–3.22, p < 0.001), age > 65 (aHR = 9.25, 95% C.I. 7.46–11.50, p < 0.001), diagnosis of cholelithiasis (aHR = 1.76, 95% C.I. 1.20–2.58, p = 0.003) and peptic ulcer disease (aHR = 1.87, 95% C.I. 1.52–2.29, p < 0.001) had significantly higher risk of osteoporosis. We propose that this correlation may be related to increased hematopoietic stress, increased consumption of nitric oxide (NO) by hemolysis, and the inhibitory effects of iron supplements on osteogenesis through the receptor activator of nuclear factor κB ligand (RANKL)/Osteoprotegerin pathway and the Runt-related transcription factor 2 (RUNX2) factor. Our findings suggest that patients with hemolytic anemia are at a higher risk of developing osteoporosis, and it would be in the patient’s best interest for physicians to be aware of this potential complication and offer preventative measures.

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Randomised trial on clinical performances and biocompatibility of four high-flux hemodialyzers in two mode treatments: hemodialysis vs post dilution hemodiafiltration

Scientific Reports ◽

10.1038/s41598-019-54404-7 ◽

2019 ◽

Vol 9 (1) ◽

Cited By ~ 1

Author(s):

Marion Morena ◽

Caroline Creput ◽

Mouloud Bouzernidj ◽

Annie Rodriguez ◽

Lotfi Chalabi ◽

...

Keyword(s):

Primary Outcome ◽

Randomised Trial ◽

High Flux ◽

Β2 Microglobulin ◽

Inflammatory Parameters ◽

Large Size ◽

Significant Difference ◽

Good Biocompatibility ◽

Very High ◽

Solute Clearance

AbstractThis prospective multicenter randomized comparative cross-over trial aimed at evaluating the influence of hemodialysis vs post-dilution hemodiafiltration with high-flux dialyzers in solute clearance and biocompatibility profile. 32 patients were sequentially dialyzed with Leoceed-21HX, Polypure-22S+, Rexsys-27H and VIE-21A. Primary outcome was β2-microglobulin removal. Secondary outcomes were (i) extraction of other uremic solutes (ii) parameters of inflammation and nutrition and (iii) comparative quantification of perdialytic albumin losses (using total ‘TDC’ vs partial ‘PDC’ collection of dialysate). Significant increases in removal rates of β2-microglobulin (84.7 ± 0.8 vs 71.6 ± 0.8 mg/L), myoglobin (65.9 ± 1.3 vs 38.6 ± 1.3 µg/L), free immunoglobulin light chains Kappa (74.9 ± 0.8 vs 55.6 ± 0.8 mg/L), β-trace protein (54.8 ± 1.3 vs 26.8 ± 1.4 mg/L) and orosomucoid (11.0 ± 1.1 vs 6.0 ± 1.1 g/L) but not myostatin (14.8 ± 1.5 vs 13.0 ± 1.5 ng/mL) were observed in HDF compared to HD when pooling all dialyzers. Rexsys and VIE-A use in both HD and HDF subgroups was associated to a better removal of middle/large-size molecules compared to Leoceed and Polypure, except β2-microglobulin for Rexsys. Inflammatory parameters were unchanged between dialyzers without any interaction with dialysis modality. Mean dialysate albumin loss was comparable between TDC and PDC (1.855 vs 1.826 g/session for TDC and PDC respectively). In addition, a significant difference in albumin loss was observed between dialyzers with the highest value (4.5 g/session) observed using Rexsys. Use of all dialyzers was associated with good removals of the large spectrum of uremic toxins tested and good biocompatibility profiles, with an additional gain in removal performances with HDF. Larger surface area, thinner wall and resultant very high ultrafiltration coefficient of Rexsys should be taken into account in its clear performance advantages.

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Family integrated care: very preterm neurodevelopmental outcomes at 18 months

Archives of Disease in Childhood - Fetal and Neonatal Edition ◽

10.1136/archdischild-2020-321055 ◽

2021 ◽

pp. fetalneonatal-2020-321055

Author(s):

Anne R Synnes ◽

Julie Petrie ◽

Ruth E Grunau ◽

Paige Church ◽

Edmond Kelly ◽

...

Keyword(s):

Cohort Study ◽

Integrated Care ◽

Maternal Employment ◽

Primary Outcome ◽

Randomised Control Trial ◽

Neurodevelopmental Outcomes ◽

Very Preterm ◽

Significant Difference ◽

Family Integrated Care ◽

Family Integrated

ObjectiveTo examine whether the family integrated care (FICare) programme, a multifaceted approach which enables parents to be engaged as primary caregivers in the neonatal intensive care unit, impacts infant neurodevelopment and growth at 18 months’ corrected age.Design/MethodsProspective cohort study of infants born <29 weeks’ gestational age (GA) who participated in the FICare cluster randomised control trial (cRCT) and were assessed in the Canadian Neonatal Follow-Up Network (CNFUN). The primary outcome measure, Cognitive or Language composite score <85 on the Bayley-III, was compared between FICare exposed and routine care children using logistic regression, adjusted for potential confounders and employing generalised estimation equations to account for clustering of infants within sites.ResultsOf 756 infants <29 weeks’ GA in the FICare cRCT, 505 were enrolled in CNFUN and 455 were assessed (238 FICare, 217 control). Compared with controls, FICare infants had significantly higher incidence of intraventricular haemorrhage (IVH) (19.5% vs 11.7%, p=0.024) and higher proportion of employed mothers (76.6% vs 73.6%, p=0.043). There was no significant difference in the odds of the primary outcome (adjusted OR: 0.92 (0.59 to 1.42) FiCare vs Control) on multivariable analyses adjusted for GA, IVH and maternal employment. However, Bayley-III Motor scores (adjusted difference in mean (95% CI) 3.87 (1.22 to 6.53) and body mass index 0.67 (0.36 to 0.99) were higher in the FICare group.ConclusionsVery preterm infants exposed to FICare had no significant difference in incidence of cognitive or language delay but had better motor development.Trial registration numberParticipants in this cohort study were previously enrolled in a registered trial: NCT01852695

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