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Biomedical subjects

Thomas E Wiswell

Publications and source records attributed to Thomas E Wiswell.

8 recordsLinked to original sources
PubMed2006

RACP's policy statement on infant male circumcision is ill-conceived.

OBJECTIVE: To conduct a critical peer-review of the 2004 Policy Statement on routine male circumcision produced by the Royal Australasian College of Physicians (RACP). METHOD: Comprehensive evaluation in the context of the research field. RESULTS: We find that the current Statement downplays the wide-ranging life-long benefits of circumcision in prevention of urinary tract infections (UTIs), penile and cervical cancer, genital herpes and chlamydia in women, HIV infection, phimosis, and various penile dermatoses, and at the same time overstates the complication rate. We highlight the many errors in the RACP Statement and note that it sidesteps making a conclusion based on circumcision's well-documented prophylactic health benefits by instead referring to the status of the foreskin at birth. In the era of preventative medicine we view this as irresponsible. CONCLUSION: The RACP's Statement on routine male circumcision is not evidence-based and should be retracted. IMPLICATIONS: In the interests of public health and individual well-being an extensive, comprehensive, evidence-based revision should be conducted so as to provide scientifically accurate, balanced information on the advantages, and also the low rate of mostly minor complications, associated with this simple procedure, which for maximum benefits and minimal risk should ideally be performed in the neonatal period.

Australia↗
PubMed2005

Histological chorioamnionitis and the risk of early intraventricular hemorrhage in infants born < or =28 weeks gestation.

OBJECTIVE: To test the hypothesis that histological chorioamnionitis (CA) is not associated with increased risk of early onset intraventricular hemorrhage (IVH). STUDY DESIGN: Clinical data were prospectively collected for 62 consecutive neonates born before 28 weeks of gestation. Placental histology for CA was performed by a pathologist unaware of the head ultrasound scan (HUS) results. The first HUS was obtained by 30 minutes of life. Follow-up HUS were performed before 24 hours and again at 48 to 72 postnatal hours of life. An IVH (grade I to IV) at less than 72 hours of life was deemed an early hemorrhage. RESULTS: Nine of the 62 (14.5%) infants had early onset IVH. In all, 29 infants were born to women with histological evidence of CA; 33 infants did not have CA. Infants did not differ in birth weight, gestational age, sex, cord blood pH, 5-minute Apgar score of <7, cesarean delivery, prenatal use of steroids, administration of tocolytics, need for resuscitation, presence of pneumothorax, platelet count at birth, or use of surfactant. Early IVH rates (3/29 in CA vs 6/33 in non-CA) were similar (p=0.48). Two infants in each group with early IVH died before 2 weeks of age. Five additional infants from the CA group developed IVH at more than 72 postnatal hours of life (late onset IVH), and two of those infants progressed to develop periventricular leukomalacia (PVL). In contrast, only three non-CA infants had late IVH and none developed PVL. Logistic regression confirmed that no perinatal variables including CA were associated with early onset IVH. CONCLUSION: Chorioamnionitis is not associated with increased risk of early IVH.

Amnion↗
PubMed2005

A multicenter, randomized, controlled trial of lucinactant versus poractant alfa among very premature infants at high risk for respiratory distress syndrome.

BACKGROUND: Available therapeutic surfactants are either animal-derived or non-protein-containing synthetic products. Animal-derived surfactants contain variable amounts of surfactant apoproteins, whereas the older-generation synthetic products contain only phospholipids and lack surfactant proteins (SPs). Both decrease morbidity and mortality rates associated with respiratory distress syndrome (RDS) among preterm infants, compared with placebo. However, excess mortality rates have been observed with non-protein-containing synthetic surfactants, compared with the animal-derived products. Evidence suggests that synthetic surfactants consisting solely of phospholipids can be improved with the addition of peptides that are functional analogs of SPs. Lucinactant is a new synthetic peptide-containing surfactant that contains sinapultide, a novel, 21-amino acid peptide (leucine and lysine repeating units, KL4 peptide) designed to mimic human SP-B. It is completely devoid of animal-derived components. OBJECTIVE: We hypothesized that the outcomes for premature infants treated with lucinactant and poractant alfa would be similar. Therefore, we compared lucinactant (Surfaxin; Discovery Laboratories, Doylestown, PA) with porcine-derived, poractant alfa (Curosurf; Chiesi Farmaceutici, Parma, Italy) in a trial to test for noninferiority. METHODS: A total of 252 infants born between 24 and 28 weeks of completed gestation, with birth weights between 600 and 1250 g, were assigned randomly in a multicenter, multinational, noninferiority, randomized, controlled study to receive either lucinactant (n = 124) or poractant alfa (n = 128) within 30 minutes of life. The primary outcome was the incidence of being alive without bronchopulmonary dysplasia (BPD) through 28 days of age. Key secondary outcomes included death at day 28 and 36 weeks postmenstrual age (PMA), air leaks, neuroimaging abnormalities, and other complications related to either prematurity or RDS. An independent, international, data and safety monitoring committee monitored the trial. RESULTS: The treatment difference between lucinactant and poractant alfa for survival without BPD through 28 days was 4.75% (95% confidence interval [CI]: -7.3% to 16.8%) in favor of lucinactant, with the lower boundary of the 95% CI for the difference, ie, -7.3%, being greater than the prespecified noninferiority margin of -14.5%. At 28 days, 45 of 119 infants given lucinactant were alive without BPD (37.8%; 95% CI: 29.1-46.5%), compared with 41 of 124 given poractant alfa (33.1%; 95% CI: 24.8-41.3%); at 36 weeks PMA, the rates were 64.7% and 66.9%, respectively. The corresponding mortality rate through day 28 for the lucinactant group was lower than that for the poractant alfa group (11.8% [95% CI: 6.0-17.6%] vs 16.1% [95% CI: 9.7-22.6%]), as was the rate at 36 weeks PMA (16% and 18.5%, respectively). There were no differences in major dosing complications. In addition, no significant differences were observed in the incidences of common complications of prematurity, including intraventricular hemorrhage (grades 3 and 4) and cystic periventricular leukomalacia (lucinactant: 14.3%; poractant alfa: 16.9%). CONCLUSIONS: Lucinactant and poractant alfa were similar in terms of efficacy and safety when used for the prevention and treatment of RDS among preterm infants. The ability to enhance the performance of a synthetic surfactant with the addition of a peptide that mimics the action of SP-B, such as sinapultide, brings potential advantages to exogenous surfactant therapy.

Biological Products↗
PubMed2003

Neonatal resuscitation.

Ten million or more newborns worldwide each year need some type of resuscitation assistance. More than 1 million babies die annually from complications of birth asphyxia. Over the past 3 decades, neonatal resuscitation has evolved from disparate, word-of-mouth teaching methods to organized programs. The most widely-used curriculum is the Neonatal Resuscitation Program, which is supported by the American Academy of Pediatrics and the American Heart Association. To date more than 1.5 million individuals have been trained in the Neonatal Resuscitation Program. Resuscitation efforts are geared toward avoiding or mitigating the adverse sequelae of asphyxia neonatorum. Certain characteristics distinguish the preterm infant, including propensity to become hypothermic and higher potential for adverse neurologic and pulmonary complications from resuscitation efforts. In this era of evidence-based medicine the most recent Neonatal Resuscitation Program guidelines were developed to provide recommendations based on the best currently-available science. A number of major proposals received considerable scrutiny during the evaluation process. Many areas of neonatal resuscitation still need to be studied.

Asphyxia Neonatorum↗
PubMed2002

A multicenter, randomized, controlled trial comparing Surfaxin (Lucinactant) lavage with standard care for treatment of meconium aspiration syndrome.

OBJECTIVE: Infants with meconium aspiration syndrome (MAS) have marked surfactant dysfunction. Airways and alveoli of affected neonates contain meconium, inflammatory cells, inflammatory mediators, edema fluid, protein, and other debris. The objective of this study was to compare treatment with bronchoalveolar lavage using dilute Surfaxin with standard therapy in a population of newborn infants with MAS. METHODS: Inclusion criteria were 1) gestational age > or =35 weeks, 2) enrollment within 72 hours of birth, 3) diagnosis of MAS, 4) need for mechanical ventilation, and 5) an oxygenation index > or =8 and < or =25. Subjects were randomized to either lavage with Surfaxin or standard care (2:1 proportion). In lavaged infants, a volume of 8 mL/kg dilute Surfaxin (2.5 mg/mL) was instilled into each lung over approximately 20 seconds followed by suctioning after 5 ventilator breaths. The procedure was repeated twice. The third and final lavage was with a more concentrated solution (10 mg/mL) of Surfaxin. RESULTS: Twenty-two infants were enrolled (15 Surfaxin and 7 control). Demographic characteristics were similar. There were trends (not significant) for Surfaxin-lavaged infants to be weaned from mechanical ventilation earlier (mean of 6.3 vs 9.9 days, respectively), as well as to have a more rapid decline in their oxygenation indexes compared with control infants, the latter difference persisting for the 96-hour-long study period. The therapy was safe and generally well tolerated by the infants. CONCLUSIONS: Dilute Surfaxin lavage seems to be a safe and potentially effective therapy in the treatment of MAS. Data from this investigation support future prospective, controlled clinical trials of bronchoalveolar lavage with Surfaxin in neonates with MAS.

Bronchoalveolar Lavage↗
PubMed2002

The history of neonatal resuscitation.

Attempts at human resuscitation date back to ancient times. Most strategies for resuscitation focused on adults until the early 1800s, when newborn resuscitation captured the interest of noted practitioners. The most promising techniques and strategies for neonatal resuscitation were developed during the latter part of the twentieth century. This article examines the key components of neonatal resuscitation and the discoveries that stimulated the development of current neonatal resuscitation practices.

Heart Massage↗
PubMedDate not supplied

Oropharyngeal and nasopharyngeal suctioning of meconium-stained neonates before delivery of their shoulders: multicentre, randomised controlled trial.

BACKGROUND: Meconium aspiration syndrome (MAS) is a life-threatening respiratory disorder in infants born through meconium-stained amniotic fluid (MSAF). Although anecdotal data concerning the efficacy of intrapartum oropharyngeal and nasopharyngeal suctioning of MSAF are conflicting, the procedure is widely used. We aimed to assess the effectiveness of intrapartum suctioning for the prevention of MAS. METHODS: We designed a randomised controlled trial in 11 hospitals in Argentina and one in the USA. 2514 patients with MSAF of any consistency, gestational age at least 37 weeks, and cephalic presentation were randomly assigned to suctioning of the oropharynx and nasopharynx (including the hypopharynx) before delivery of the shoulders (n=1263), or no suctioning before delivery (n=1251). Postnatal delivery-room management followed Neonatal Resuscitation Program guidelines. The primary outcome was incidence of MAS. Clinicians diagnosing the syndrome and designating other study outcomes were masked to group assignment. An informed consent waiver was used. Analysis was by intention to treat. FINDINGS: 18 infants in the suction group and 15 in the no suction group did not meet entry criteria after random assignment. 87 in the suction group were not suctioned, and 26 in the no suction group were suctioned. No significant difference between treatment groups was seen in the incidence of MAS (52 [4%] suction vs 47 [4%] no suction; relative risk 0.9, 95% CI 0.6-1.3), need for mechanical ventilation for MAS (24 [2%] vs 18 [1%]; 0.8, 0.4-1.4), mortality (9 [1%] vs 4 [0.3%]; 0.4, 0.1-1.5), or in the duration of ventilation, oxygen treatment, and hospital care. INTERPRETATION: Routine intrapartum oropharyngeal and nasopharyngeal suctioning of term-gestation infants born through MSAF does not prevent MAS. Consideration should be given to revision of present recommendations.

Adult↗