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Biomedical subjects

D D McMillan

Publications and source records attributed to D D McMillan.

At least 19 recordsLinked to original sources

Consent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study.

BACKGROUND: Recruitment into research studies in the neonatal intensive care unit has been problematic. Therefore suggestions have been made to take decision making about enrollment out of the hands of the parents. OBJECTIVE: To understand parental perceptions of the process of recruitment and enrollment for research in the neonatal intensive care unit. METHOD: A questionnaire was developed and used in both a retrospective survey and a prospective study of parents whose newborns were enrolled in trials in a neonatal intensive care unit. Closed ended and open ended questions were included, as well as demographic questions. RESULTS: The retrospective survey had a 79% response rate (29 of 38). Overall, 90% of parents felt that they had made informed decisions, and 93% were against the option that a doctor decide if the newborn should be enrolled into a study, rather than the parent. Although some parents (38%) found that recruitment did add "stress to an already stressful situation", 90% felt that they had made informed decisions and understood the elements of the study. Most parents had been requested to enroll their newborn into more than one trial, and, on average, they thought that they would be comfortable with enrollment into two studies (range 0-6). When asked how the process could be improved, parents suggested that information be made available before delivery. The responses of parents in the prospective study were mostly consistent with those from the retrospective survey. CONCLUSIONS: Overall the parents did not support the suggestion that decision making about enrollment be taken away from parents and put into the hands of doctors. The healthcare team should support parents in their role of decision maker, enhance availability of the research staff, and provide more information about the research.

Attitude↗

Evaluation of the effectiveness of the standardized neonatal resuscitation program.

OBJECTIVE: To determine if health care personnel trained in the Neonatal Resuscitation Program (NRP) used the NRP guidelines in the resuscitation of newborn babies. To determine differences between self-reporting and documentation of resuscitation in medical records. STUDY DESIGN: Using a validated questionnaire, individuals participating in resuscitation of newborns voluntarily phoned and answered questions on an Interactive Voice Response (IVR) system. The study was undertaken in level II hospitals in Southern Alberta with 7500 deliveries per year. RESULTS: Of the 5155 babies delivered during the study, 16% required resuscitation (bag and mask ventilation 10.6%, intubation for meconium or intermittent positive pressure ventilation, IPPV, 3.6%, cardiac massage, CM, 0.3%, epinephrine 0.1%, naloxone 6.9%). Of babies whose interventions could be assessed, bag and mask was correct in 99%, endotracheal intubation for IPPV in 100%, and CM in 100%. Only 75% of babies had meconium managed correctly and 92% had naloxone administered according to guidelines. There were more instances where IVR (48) reported a procedure, which was not charted versus charted and not reported by IVR (21). Educational needs identified by IVR included skills of resuscitation and NRP indications for management. CONCLUSION: Bag and mask ventilation and intubation for neonatal resuscitation are more common than previously reported. Management of the meconium-stained baby and use of naloxone require further education. Compared to charts, use of IVR system allows more complete documentation with rationale of interventions and identification of continuing educational needs.

Guideline Adherence↗

Problem-based teaching of birth attendants in the Philippines.

We compared the effects of lecture-style (L) and interactive problem-based (I) educational programs on knowledge, attitude, and practices (KAP) of traditional birth attendants in the Philippines. Participants in two cities were randomized to L and I teaching groups and completed a questionnaire pre-, immediately post-, and 6 months after education. Mothers reported practices of the attendants. There was significant improvement in mean knowledge scores (L 16.8 to 17.9 and I 16.4 to 19.3) in group I. Group I scores continued to improve 6 months later. Attitude scores significantly improved in both groups and decreased 6 months later, indicating a need for reinforcement. Certain undesirable practices such as late cord clamping and holding the baby upside down following birth were changed in both groups. Actual practices reported by mothers were carried out less frequently than indicated by providers, indicating a need for further education and possibly provision of adequate resources. Interactive (I) learning is a preferred method for education of traditional birth attendants.

Female↗

Variations in practice and outcomes in the Canadian NICU network: 1996-1997.

BACKGROUND: Previous reports of variations in outcomes among neonatal intensive care units (NICUs) examined only specific subpopulations of interest (eg, very low birth weight [VLBW] infants <1500 g of birth weight [BW]). OBJECTIVES: We report on current practice and outcomes variations in a population-based national study of Canadian NICUs from January 8, 1996 to October 31, 1997. METHOD: Information on 20 488 admissions to 17 tertiary level NICUs across Canada was prospectively collected by trained abstractors using a standard manual of operations and definitions. Data were verified and analyzed in concert with a steering committee comprising experienced researchers and neonatologists. Patient information included demographic information, antenatal history, mode of delivery, problems at delivery, status of infant and problems at birth, illness severity (Clinical Risk Index for Babies, Score for Neonatal Acute Physiology, Score for Neonatal Acute Physiology-Version II), therapeutic intensity (Neonatal Therapeutic Intensity Scoring System [NTISS]), selected NICU practices and procedures, use of technology and resources, and selected patient outcomes. Patients were tracked until death or discharge home. RESULTS: The mean number of annual admissions to an NICU was 657, with 26% outborn infants. Fifty-three percent were <2500 g BW, 20% were <1500 g BW (VLBW), and 65% were preterm (<38 weeks' gestational age [GA]). Only 2% of mothers received no prenatal care. Antenatal steroids were given to 58%, but there was wide variation in use (23%-76%). Congenital anomalies were present in 14%, and 4% were small for GA (less than the third percentile). Admission illness severity was lowest among infants 33 to 37 weeks of GA and correlated with risk of death. Ninety-six percent of patients survived until discharge, but fewer survived at lower GA. No infant <22 weeks' GA survived. Seven percent of infants had at least 1 episode of infection, but 75% received antibiotics in the NICU. Forty-three percent received respiratory support, and 14% received surfactant. Nitric oxide was given to 150 term infants and to 102 preterm infants. Selected outcomes of VLBW infants were: survival rate (87%); chronic lung disease (26%); >/=stage 3 retinopathy of prematurity (ROP; 11%); >/=grade 3 intraventricular hemorrhage (IVH; 10%); nosocomial infection (22%); necrotizing enterocolitis (NEC; 7%). Sixty-nine percent of VLBW infants survived without major morbidity (>/=grade 3 IVH, chronic lung disease, NEC, >/=grade 3 ROP). The mean duration of NICU stay was 19 days. Forty-seven percent of infants were discharged from the hospital, and 43% were retrotransferred to a community facility before discharge home. Significant variation in practices and outcomes were observed in all aspects of NICU care. CONCLUSION: This study provides population-based information about NICU outcomes. Significant variation in NICU practices and outcomes was observed despite Canada's universal health insurance system. This national database provides valuable information for planning research, allocating resources, designing health and public policy, and serving as a basis for longitudinal studies of NICU care in Canada.

Birth Weight↗

Tracheal aspirate surface tension in babies with hyaline membrane disease: effects of synthetic surfactant replacement.

Our objective was to determine changes in surface tension of tracheal aspirate over the first 4-5 days of life in babies with hyaline membrane disease, with and without synthetic surfactant replacement. Tracheal aspirates were collected prior to and for 96-108 hr after initiation of a randomized double-blind trial of synthetic surfactant (EXOSURF Neonatal) or air-treated control patients. Using the captive bubble technique, we measured minimum surface tension (initial adsorption, first quasi-static compression, dynamic cycling at 30 cpm, second quasi-static compression and 5 min after quasi-static compressions) in 39 surfactant-treated and 44 control babies. We also compared minimum surface tension with the respiratory support provided. Twelve hours after one dose of synthetic surfactant, minimum surface tension on first quasistatic compression decreased significantly from 20.9+/-1.4 to 17.6+/-1.3 mN/m compared to air-treated babies, who did not show any change. Reduction in minimum tracheal aspirate surface tension on first quasi-static compression and during dynamic cycling over 48-60 hr occurred more rapidly in surfactant-treated babies. Ventilator support did not correlate with minimum tracheal aspirate surface tension. We conclude that treatment of babies with synthetic surfactant improved tracheal aspirate minimum surface tension within 12 hr of the first dose and for the next 48-60 hr.

Double-Blind Method↗

Plasma L-arginine concentration, oxygenation index, and systemic blood pressure in premature infants.

OBJECTIVE: To determine the relationships between plasma L-arginine concentrations and the severity of respiratory distress syndrome (RDS) or systemic blood pressure in premature infants. DESIGN: Prospective, observational study. SETTING: Neonatal intensive care, tertiary referral hospital. SUBJECTS: Fifty-three premature infants. INTERVENTIONS: We measured arginine and nutritional intake, plasma arginine concentration, total amino acid concentrations, and blood pressure on days 3, 7, 14, and 21 of life. In 33 infants who received assisted ventilation, oxygenation index could be calculated to reflect the severity of RDS. The relationships between plasma arginine and oxygenation index or blood pressure were analyzed using multiple linear regression. MEASUREMENTS AND MAIN RESULTS: On day 3, plasma arginine concentrations were decreased compared with normal published values. Arginine concentrations increased with the day of life of measurement (p < .001) and with arginine intake (p < .001). After adjusting for arginine intake and day of life, an inverse relationship was found between oxygenation index and plasma arginine concentrations: (p = .025). No similar relationship was found between oxygenation index and the concentration of total amino acids. A weak positive relationship was found between plasma arginine concentration and systemic blood pressure. CONCLUSIONS: Increments in the oxygenation index, reflective of an increased severity of RDS, are associated with a decrease in plasma arginine concentration. This finding may reflect arginine consumption by the nitric oxide synthase pathway in the lungs of premature infants with RDS, or may be explained by increased arginine catabolism. The lack of a similar relationship between total plasma amino acids and oxygenation index supports the first interpretation.

Amino Acids↗

Plasma L-arginine concentrations in premature infants with necrotizing enterocolitis.

OBJECTIVE: To determine whether L-arginine concentrations (the substrate for nitric oxide synthesis) are lower in premature infants in whom necrotizing enterocolitis (NEC) develops than in unaffected infants. METHODS: We measured arginine and nutritional intake, plasma arginine, glutamine, total amino acids, and ammonia concentrations in 53 premature infants (mean gestational age +/- SD: 27 +/- 1.7 weeks) at risk of NEC. Measurements were done on days 3, 7, 14 and 21 and just before treatment in infants with NEC. RESULTS: Necrotizing enterocolitis developed in 11 infants between postnatal days 1 and 26. On day 3, plasma arginine concentrations were decreased compared with normal published values (mean +/- SE, 41 mumol/L +/- 4). Arginine concentrations increased with day of life of measurement (p < 0.001) and arginine intake (p < 0.001). Plasma arginine concentrations were significantly lower at the time of diagnosis in infants with NEC compared with control subjects, even after adjusting for arginine intake and day of life (p = 0.032). Plasma glutamine and total amino acid concentrations were not significantly different in infants with NEC compared with control subjects. Plasma ammonia concentrations were elevated on day 3 (mean +/- SE, 72 +/- 3.3 mumol/L) and decreased with postnatal age (p < 0.001) and increasing plasma arginine concentrations (p < 0.001). CONCLUSION: Plasma arginine concentrations are decreased at the time of diagnosis in premature infants with NEC. The potential benefit of arginine supplementation in the prevention of the disease deserves evaluation.

Age Factors↗

Administration of Vitamin K to newborns: implications and recommendations.

The review by Drs. Brousson and Klein (see pages 307 to 315 of this issue) identifies controversies surrounding the administration of vitamin K to babies shortly after birth. Controlled studies comparing the effect of oral and intramuscular administration are unlikely to be conducted because of the large number of subjects needed. The evidence presented in the review should dispel concerns that intramuscular administration may be associated with childhood cancer. Oral administration of a single dose of vitamin K soon after is associated with significant biochemical vitamin K deficiency by 1 month of age, but the relation of biochemical abnormality to clinical manifestations of late hemorrhagic disease of the newborn is less clear. Epidemiologic studies indicate a small, but significant, increase in the incidence rate of hemorrhagic disease after oral administration of vitamin K (1.0 to 6.4 incidents per 1000 000 infants), compared with the incidence rate after intramuscular administration (0.25 incidents per 100 000 infants). Although repeated oral doses of vitamin K may be and effective alternative regimen, there is no approved oral vitamin K formulation, there are concerns about patient compliance, and there has been limited investigation of such regimen. Therefore, intramuscular administration of a single dose of 1.0 mg of vitamin K shortly after birth is recommended.

Administration, Oral↗

Effect of educational program and interview on adoption of guidelines for the management of neonatal hyperbilirubinemia.

OBJECTIVES: To determine (a) whether physicians are adhering to the guidelines for the management of neonatal hyperbilirubinemia, (b) what influences their decisions to investigate and treat the condition and (c) the effect of an educational program and clinical recall interview on compliance with the guidelines. DESIGN: Retrospective chart audit. SETTING: Urban tertiary care hospital. PARTICIPANTS: All term neonates who received phototherapy but were not admitted to the neonatal intensive care unit. INTERVENTIONS: Educational program and clinical recall interview. MEASURES: Charts were reviewed from March to May 1986 (period I, before publication of the guidelines) and from November 1986 to January 1987 (period II, after publication and after the educational program). The audits were repeated from April to June 1989 (period III, during the interview phase) and from October to December 1989 (period IV, 6 months after the interviews). Two criteria determined the appropriate use of phototherapy: the serum bilirubin level and the postnatal day on which phototherapy was started. RESULTS: The proportion of infants receiving phototherapy for whom there were orders for complete blood counts to investigate hyperbilirubinemia increased from 20% in period I to 37% in period IV. The frequency of orders to determine the proportion of reticulocytes did not change significantly. The number of infants receiving phototherapy decreased over the study periods. The proportion receiving phototherapy in accordance with the criteria for the serum bilirubin level increased from 10% to 17% after the educational program (insignificant difference) and to 31% after the interviews (p = 0.02). Compliance with the guidelines was greater before the infants were 2 days old than when they were 3 days old or more (p = 0.01). Of the 45 physicians who prescribed phototherapy (for 94 infants) during period IV 26 never prescribed in accordance with the guidelines. The other 19 prescribed in accordance with the guidelines for 30 of 52 infants. Decisions to investigate and treat with phototherapy were affected by clinical and parental factors in addition to the guidelines. Two of the 25 physicians interviewed stated that the interview would influence their management of future cases of hyperbilirubinemia. CONCLUSION: A clinical recall interview can have a greater impact on changing physician management practices than factual communication on a group basis.

Attitude of Health Personnel↗

Nutrition and growth analysis of very low birth weight infants.

The growth and nutrition of 220 very low birth weight infants were reviewed after comprehensive data on all infants in the hospital were entered into the Neonatal Intensive Care Unit Audit Data Base for 2 years prospectively. Fluid and energy (parenteral and oral) intakes were compared in four birth weight categories (1, less than or equal to 750 g; 2, 751 to 1000 g; 3, 1001 to 1250 g; 4, 1251 to 1500 g). Parenteral nutrition was the major source of first nutrition for the small infants, but seldom did it alone provide adequate nutrition for very low birth weight infants. The age of the first nutrition (parenteral and/or oral nutrition other than dextrose) decreased with increasing birth weight. The age of the first oral feedings was later for the infants of the lower birth weights but enteral feeding became the major nutrition for all weight categories by the second week of life. During the first 50 days the infants accumulated a deficit of 3780 to 5460 kJ relative to their estimated need of 504 kJ/kg per day, with the smaller infants accumulating a significantly larger deficit. The growth of infants appropriate for gestational age and of infants small for gestational age differed from each other and from the commonly used graph of Dancis et al (J Pediatr. 1948;33:570-572).

Alberta↗

Home oxygen therapy. Outcome of infants discharged from NICU on continuous treatment.

Forty-four oxygen-dependent infants were discharged home in oxygen from an NICU during an 8-year period. Survivors were followed for 3 years. The infants' discharge diagnoses were bronchopulmonary dysplasia (BPD) (39), sleep apnea (2), and congenital cardiac defects (3). The five infants who had diagnoses other than BPD all died, but 34 of 39 infants with BPD survived. Supplemental oxygen was discontinued at a mean age of 13.4 months. The infants with BPD experienced health, growth, nutritional, neurodevelopmental and sensory problems that necessitated frequent rehospitalizations and utilization of a variety of medical and support services.

Bronchopulmonary Dysplasia↗

The histopathology of the upper airway in the neonate following mechanical ventilation.

Laryngotracheobronchial lesions were carefully documented in 26 neonatal autopsies and were classified into two main types. Type I lesions were focal desquamative or ulcerative, asynchronous, and variable in severity involving areas exposed to contact with endotracheal tube or suction catheter. These lesions are most likely due to trauma of artificial ventilation. Type II lesions were diffuse, necrotizing, more synchronous and uniform in severity involving tissues distal to the endotracheal tube and extending to second or third generation bronchi. The early or mild type II lesions consisted of coagulative necrosis of epithelial cells and mucosal oedema. The late or severe type II lesions showed features similar to those of necrotizing tracheobronchitis described by Metley et al. All the cases with type II lesions had been ventilated with 100 per cent oxygen continuously for at least 3 h during life. The use of pure oxygen may be an important factor leading to necrotizing tracheobronchitis.

Bronchi↗

Bolus and continuous infusion of tolazoline in neonates with hypoxemia.

We randomly assigned 24 neonates with hypoxemia to receive tolazoline hydrochloride. Thirteen received a single dose (SD) of 2 mg/kg intravenously, and 11 received a SD of 2 mg/kg plus a 2 mg/kg/h intravenous infusion (SDI). Increase in PaO2 greater than or equal to 15 mm Hg within 20 min of administration was more common in SDI patients. Hypotension and gastrointestinal bleeding occurred more often in SDI patients. Survival could not be related to the method of administration or initial relief of hypoxemia with tolazoline.

Female↗

Benefits of orotracheal and nasotracheal intubation in neonates requiring ventilatory assistance.

To investigate differences in orotracheal (OT) and nasotracheal (NT) intubation for ventilatory assistance, we randomly assigned 91 neonates to be intubated via either of the two routes: 46 infants were assigned to the OT group and 45 infants were assigned to the NT group. Inability to intubate the nostril in three neonates, and respiratory or cardiac instability during attempted NT intubation in three neonates, resulted in the assignment of 52 infants to the OT group and 39 infants to the NT group; patients in both groups were of comparable size, sex, and clinical problems. Initial malposition of the endotracheal tube and need to retape, reposition, or replace the tube during the mean duration of intubation of 247 +/- 42 hours for the OT group and 273 +/- 57 hours for the NT group were similar. Daily Gram stains of tracheal aspirates showed that inflammation (greater than or equal to ten polymorphonuclear cells per 400 power fields) was common (51% OT group, 53% NT group). Cultures grew potential pathogens in 37% of the patients from the OT group and 31% of the NT group. There was no difference in the clinical or radiologic incidence of pneumonia. Postextubation problems were comparable: atelectasis, 48% OT and 59% NT; stridor, 15% OT and 26% NT. OT intubation may be preferred for prolonged ventilatory assistance in neonates because of the relative ease of initial intubation.

Female↗

Necrotizing enterocolitis: a chronic colonic disease.

While acute necrotizing enterocolitis is a common neonatal condition, the chronicity of the pathologic process is often overlooked. Between 1979 and 1983 at the Foothills Hospital in Calgary, a diagnosis of acute necrotizing enterocolitis was made in 211 infants. Seventeen infants (8%) required urgent surgical treatment in addition to standard medical management. Overall, 206 (98%) infants survived the acute episode. Long-term survival was 92% (194 children). The 12 late deaths were ascribed to chronic cardiovascular, pulmonary and cerebral diseases and "short gut syndrome". Colonic strictures developed in 9% of those treated medically; strictures distal to the mucous fistula developed in 50% of those requiring urgent resection and exteriorization. None of the strictures, which formed between 14 days and 18 months after the diagnosis was made, resolved spontaneously. They tended to be multiple and to involve longer segments in infants who required surgery. Diarrhea prolonged the morbidity in these children. The time course and varied presentation of strictures in this series suggests a rationale for management of infants who survive acute necrotizing enterocolitis.

Chronic Disease↗