Preterm received bovine colostrum as trophic feeding

Late Onset Neonatal Sepsis

Necrotizing Enterocolitis of Newborn

Feeding; Difficult, Newborn

Bovine colostrum

Medicin

Gut Priming With Oral Bovine Colostrum for Preterm Neonates; Randomized Control Trial

Effect of Bovine Colostrum On T-Regulatory Cells, Prevention Of Late Onset Sepsis And Necrotizing Enterocolitis In Preterm Neonates

Incidence of Late Onset Sepsis in the studied group measured by rodwell and tollner sepsis scoring system

Incidence of Necrotizing Enterocolitis in the three groups diagnosed according to bell's staging

Active T regulatory cells diagnosed by cell CD 4 expressing CD 25 high or simultaneously CD 25 plus FOXP3

Rania Ismail

Clinical professor

Ain Shams University

We will develop a nomogram for warfarin dosing that uses rapid turnaround genetic testing and monthly nomogram modification (if necessary) to achieve effective and safe warfarin induction and maintenance. More than 70% of the time, we will maintain warfarin naïve patients within the target therapeutic range. The percent of time in the therapeutic range will be analyzed beginning 2 weeks after initiation of warfarin. Analyses will be stratified by the indication for anticoagulation.

Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.
Doses were subsequently adjusted based on serial INR measurements.

Dosing Algorithm A

Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.

Dosing Algorithm B

Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.

Dosing Algorithm C

Total

Sex: Female, Male

Region of Enrollment

Primary end point: mean percentage of time INR is within therapeutic range. Though target INR was 2.0-3.0, therapeutic INR is considered 1.8-3.2 (allows for INR measurement error and avoids problems inherent in overcorrection).
The international normalized ratio (INR) is one way of presenting prothrombin time test results for people taking the blood-thinning medication warfarin. The INR formula adjusts for variation in laboratory testing methods so that test results can be comparable.

Mean Percentage of Time That INR Within Therapeutic Range Using Linear Interpolation (Rosendaal et al).

The INR (international normalized ratio) is a derived measure of the prothrombin time. In this trial, a therapeutic INR was considered 1.8 to 3.2

Time to the First Therapeutic INR.

Per-patient Percentage of INRs Out of the Therapeutic Range

Defined as two consecutive INRs within the therapeutic range >7 days apart and with no dose change during this time.

Time to Stable Anticoagulation (in Days).

Defined as an INR>4.0, use of vitamin K, major bleeding events (as defined by the Thrombolysis in Myocardial Infarction [TIMI] criteria), thromboembolic events, stroke (all cause), myocardial infarction, and death (all cause).

Proportion of Patients With Serious Adverse Clinical Events.

Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.
Doses were subsequently adjusted based on serial INR measurements.

Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.

Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data. Simulations using Algorithm C were repeated using the clinical endpoints described above to derive the optimal starting warfarin doses and titration scheme that was tested prospectively in subsequent patients enrolled in the CROWN study.

Overall Study

Mark A. Creager

Pulmonary Embolism

Deep Vein Thrombosis

Atrial Fibrillation

2 mg tablets take as directed by study staff (based on INR)

intracranial hemorrhages/diarree

Gut Priming With Oral Bovine Colostrum for Preterm Neonates; Randomized Control Trial

Study to Develop a Reliable Nomogram That Incorporates Clinical and Genetic Information

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