Neonatal Intensive Care Form (NIC) Instructions for Completing Form Participant Group: This form is completed for each live born infant admitted to the NICU/Immediate care nursery for the MOTOR study. Form Purpose: This form documents the infant’s potential conditions and/or diagnoses. When completed: This form should be completed at the time of NICU/Immediate care nursery admission. Who completes: MOTOR staff trained by the Study Coordinator for data collection. Other Documents: Other forms include the Neonatal Baseline Form (NBF) and the Serious Adverse Event Form (SAE). Form Instructions: Header: ID: Attach Participant ID label, or record Participant ID. Name: Record the participant’s name (this is not data entered). Staff ID: Record initials of staff collecting NIC data. Date: Record date of NIC data collection. Special Instructions: All information should be obtained from the infant chart, either paper or electronic. If an infant was diagnosed and assigned the ICD-9 code for a condition then answer YES for that condition. Instructions on How to Complete Form Items Question 1: Date of NICU Admission Give the date of the first admission, if there is more than one. Question 2: Hospital Name if not Study Site Write the name of the hospital if it is not the study hospital. Question 3: Neonatal Blood Gas Done? Answer YES if neonatal blood gases were measured. If Yes: Item a: First neonatal arterial pH Record the first arterial blood gases obtained after admission to the NICU. Item b: First neonatal base excess Record the base excess of arterial blood gases here. Please note that your lab may report base deficit rather than excess. If your lab reports base deficit, convert it to excess by changing a negative sign to a positive sign, or vice versa. For example, if your lab reports a base deficit of: -9.6 you will convert to base excess and record as: 9.6 Question 4: Total Bilirubin Done? Answer Yes if Bilirubin was measured If Yes: NIC_QxQ / November 17, 2004 Page 1 of 5 Item a: Highest total bilirubin Enter the highest total bilirubin reached during hospital stay. Item b: Date If the bilirubin was measured, record the date of the highest measurement. Item c: Time If the bilirubin was measured, record the time of the highest measurement. Question 5: Transient tachypnea (TTN) Answer YES if the infant was diagnosed with transient tachypnea, ICD-9 code 770.6 of the newborn. TTN is occasionally referred to as ‘RDS Type II’. Also answer YES for infants weighing >1000 grams and requiring oxygen therapy and/or mechanical ventilation/CPAP during the first 24 hours of life, but who do not demonstrate evidence of other causes of respiratory distress (such as HMD). Question 6: Respiratory Distress Syndrome Answer YES if the infant was diagnosed as suffering from ‘Type I RDS’, ICD-9 Code 769, and received at least 24 hours of oxygen therapy. Include those infants diagnosed as suffering from Hyaline Membrane Disease (HMD) ICD-9 Code 769 or Respiratory Insufficiency of Prematurity (RIP) ICD-9 Code 770.89, as defined below. HMD will be diagnosed in infants with respiratory distress who demonstrate grunting respirations, retractions, an increased oxygen requirement (FiO2 >0.40), and diagnostic x-ray findings of a reticulogranular pattern in the absence of other evident cause of respiratory distress. RIP will be diagnosed in infants weighing less than 1,000 grams at birth, who require oxygen therapy and/or mechanical ventilation/CPAP in the absence of HMD or other evident cause of respiratory distress. Answer YES if the infant died before 24 hours of age, and received a clinical diagnosis of RDS Type I and oxygen therapy (FiO2 >0.40). Question 7: Pneumonia Answer YES if pneumonia was diagnosed clinically (ICD-9 Codes 486 or 770.0) and confirmed by either an x-ray demonstrating consolidation with air bronchograms, or a positive blood culture performed at the time of clinical diagnosis. Question 8: Bronchopulmonary dysplasia Record YES if infant received oxygen therapy (with or without mechanical ventilation/CPAP) and has an oxygen requirement (FiO2 > 0.21) for more than the first 28 days. The infant does not have BPD if it dies before 28 days of life. X-ray findings may demonstrate pulmonary fibrosis and hyper-expanded lung fields. Question 9: Chronic Lung disease Record YES if the infant was hospitalized, diagnosed with CLD (ICD-9 code 770.7) and received a supplemental O2 at 36 weeks gestation, using the first U/S for gestational dating. Record NO if the patient was hospitalized but did not receive supplemental oxygen at the 36 week date or was 37 weeks at birth. Question 10: Respiratory Support Record Yes, if the neonate required respiratory support. Record No, if the neonate did not require respiratory support. If yes, check all items a-d that apply as modes of respiratory support. NIC_QxQ / November 17, 2004 Page 2 of 5 Question 11: Duration of ventilator support Record the total calendar days on ventilator, including multiple periods on ventilator. Count the number of calendar days on which the baby received treatment at some point during the day (e.g., if the baby was started at noon on one day and taken off at noon the following day, this would count as two calendar days rather than one). Question 12: Duration of supplemental oxygen Record the number of calendar days that the infant received supplemental oxygen (FiO2 > 0.21) after admission to nursery from Labor and Delivery (e.g., if the baby was started at noon on one day and taken off at noon the following day, this would count as two calendar days rather than one). Record "000" if no oxygen was administered outside Labor and Delivery. If infant receives oxygen while also on the ventilator include those days in the totals for question 11. Question 13: Received Surfactant Record YES if the infant received surfactant. Question 14: Received Indomethacin Record YES if the infant received indomethacin. Question 15: Pneumothorax Record YES if the infant was diagnosed with pneumothorax- ICD-9 Code 770.2. Question 16: Necrotizing enterocolitis requiring medical or surgical treatment Answer yes if any of the three stages are diagnosed (ICD-9 codes 777.5 or 777.8). Stage 1 (Suspected NEC) - Systemic signs include temperature instability, apnea, bradycardia, and lethargy. Intestinal signs include elevated pre-gavage residuals, mild abdominal distension, emesis, and heme-positive stools or possible bright red blood from rectum. Radiologic signs include normal or intestinal dilatation and mild ileus. Stage 2 (Definite NEC, mildly to moderately ill) - Systemic signs include those from Stage 1, plus possible mild metabolic acidosis or mild thrombocytopenia. Intestinal signs include those from Stage 1, plus absent bowel sounds, +/- abdominal tenderness, and possible +/- abdominal cellulitis or right lower quadrant mass. Radiologic signs include intestinal dilatation, ileus, and pneumatosis intestinalis, plus possible portal vein gas and +/- ascites. Stage 3 (Advanced NEC, severely ill with intact or perforated bowel) - Systemic signs include those from Stage 2, plus hypotension, bradycardia, severe apnea, combined respiratory and metabolic acidosis, DIC, and neutropenia, possible mild metabolic acidosis or mild thrombocytopenia. Intestinal signs include those from Stage 2, plus signs of generalized peritonitis, marked tenderness, and distension of abdomen. Radiologic, surgical, or autopsy signs include those from Stage 2, plus definite ascites or pneumoperitoneum. If yes, was treatment required: Answer yes, if participant received treatment. Question 17: Patient ductus arteriosus requiring medical or surgical treatment Answer YES if PDA (ICD-9 Code 747.0) requiring therapy was noted in the chart. Question 18: Persistent pulmonary hypertension? Answer YES if the pulmonary hypertension (ICD-9 codes 416.0 or 747.83) is diagnosed and is not secondary to anatomic congenital heart disease and is documented or strongly suggested by: direct measurement at catheterization demonstration of right-to-left shunt through the ductus arteriosus (by a PO2 in the right radial, brachial, or temporal artery that is at least 15 mm greater than the simultaneous PO2 measured below the ductus - usually from an umbilical or tibial artery catheter) NIC_QxQ / November 17, 2004 Page 3 of 5 a 15 mm or more increase of measurement of PO 2 measured below the ductus following the administration of tolazoline (priscoline) without other changes in therapy. The shunt may also be suspected or diagnosed by echocardiography. Question 19: Proven sepsis Answer YES if cultures of blood, CSF, or urine (catheterized or suprapubic) are positive with suspicious clinical findings of infection on physical examination of the infant, OR (in the absence of positive cultures) there is clinical evidence of cardiovascular collapse or an unequivocal X-ray confirming infection in an infant who is believed to be clinically septic. Question 20: Suspect sepsis Answer YES if there are suspicious clinical findings of infection on physical examination of the infant, but cultures performed are negative and X-rays are nonconfirmatory. Note that simply being at risk for sepsis (e.g., because of prolonged membrane rupture, prematurity, intrapartum maternal fever, or antibiotic use in the newborn) does not meet the necessary criteria for “suspect sepsis”. Question 21: Cranial sonogram or CT performed Answer YES if a sonogram or CT of the head were performed on the infant. If YES, Most severe Grade IVH Enter the most severe grade of intraventricular hemorrhage as noted from the sonogram or CT. 0 = None (ICD-9 Code 772.10) 1 = Grade I (ICD-9 Code 772.11) 2 = Grade II (ICD-9 Code 772.12) 3 = Grade III (ICD-9 Code 772.13) 4 = Grade IV (ICD-9 Code 772.14) Question 22: PVL Enter YES if the neonate was diagnosed with periventricular leukomalacia, ICD-9 Code 779.7. Question 23: Other intracranial hemorrhage Answer YES if any other intracranial hemorrhage is noted on the head CT (ICD-9 Code 767.0) Question 24: Seizures Answer NO if seizure activity is neither diagnosed nor suspected. Answer YES when the attending physician or nurse records questionable seizures, or when the attending physician or nurse believes that seizures definitely occurred. A diagnosis with and ICD-9 Code of 769 or a positive EEG may be available to confirm this diagnosis. Question 25: Retinopathy of prematurity Answer YES if the infant was been diagnosed with retinopathy of prematurity or ICD-9 Code 362.21 is assigned. Question 26: Transferred from birth hospital NICU If sent to chronic care, answer NO, and skip to 28b IF YES, A. Specify where baby was transferred 1 = Birth hospital, another unit 2 = Transferred to another hospital, NICU 3 = Transferred to another hospital, non-NICU B. record date of transfer Question 27: Final status of infant Circle the infant’s final status. If the infant was transferred to another hospital, continue to follow the infant until the final status is known. Code as follows: NIC_QxQ / November 17, 2004 Page 4 of 5 1 = Outcome unknown 2 = Died before final discharge - Complete a Serious Adverse Event Form, notifying both the site IRB and DSCC within 24 hours. 3 = Transferred to chronic care facility 4 = Discharged home Item a: Date of discharge Record the date the infant was discharged home or transferred to another hospital. Item b: If infant died If infant died- Complete SAE Enter Cause of Death, date and time of death. NIC_QxQ / November 17, 2004 Page 5 of 5