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Neonatal rct

Samantha K Shirk, Stephanie A Manolis, Donna S Lambers, Kathleen L Smith
BACKGROUND: It has been established that delayed umbilical cord clamping in preterm infants results in improvement in neonatal anemia, need for transfusion, incidence of necrotizing enterocolitis, and intraventricular hemorrhage by increasing neonatal circulating blood volume. However, the effects of umbilical cord milking as an alternative to delayed clamping in preterm infants are unclear. OBJECTIVE: The primary objective of this study was to compare the effect of delayed clamping versus milking of the umbilical cord on the initial hematocrit concentration in preterm births (23-34 weeks)...
February 5, 2019: American Journal of Obstetrics and Gynecology
Georg M Schmölzer, Gerhard Pichler, Anne Lee Solevåg, Caroline Fray, Sylvia van Os, Po-Yin Cheung
BACKGROUND: The need for cardiopulmonary resuscitation (CPR) is often unexpected, and the infrequent use of CPR in the delivery room (DR) limits the opportunity to perform rigorous clinical studies to determine the best method for delivering chest compression (CC) to newborn infants. The current neonatal resuscitation guidelines recommend using a coordinated 3:1 compression-to-ventilation (C:V) ratio (CC at a rate of 90/min and ventilations at a rate of 30/min). In comparison, providing CC during a sustained inflation (SI) (CC + SI) significantly improved hemodynamics, minute ventilation, and time to return of spontaneous circulation (ROSC) compared to 3:1 C:V ratio in asphyxiated piglets...
February 19, 2019: Trials
Yang Zhao, Rui Hou, Xiu Zhu, Lihua Ren, Hong Lu
BACKGROUND: The majority of current evidences simply showed the short-term benefits of delayed cord clamping, mainly focusing on the first week after birth. Without follow-up data, we can hardly come to the conclusion that delayed cord clamping may do more harm than good. OBJECTIVE: To evaluate the long-term effects of delayed cord clamping compared with early cord clamping on infants after neonatal period. DESIGN: Systematic review and meta-analysis of randomized controlled trials (RCTs)...
February 8, 2019: International Journal of Nursing Studies
Faustino R Pérez-López, Peter Chedraui, Gonzalo R Pérez-Roncero, Samuel J Martínez-Domínguez
OBJECTIVE: To assess the efficacy of cervical pessary application for the prevention of spontaneous preterm birth (SPB) in singleton pregnancies with a sonographically measured short cervix. METHODS: Searches were conducted in PubMed-Medline, Embase, Scopus, Web of Science, and Cochrane Library, and clinical trial registries for randomized controlled trials (RCTs) published in all languages from inception through 28 July 2018. Inclusion criteria were registered RCTs of singleton pregnants with a short cervix (≤ 25 mm) measured at 22-24 weeks comparing the use of a cervical pessary versus controls over the risk of SPB...
February 19, 2019: Archives of Gynecology and Obstetrics
A Eapen, M Joing, P Kwon, J Tong, E Maneta, C De Santo, F Mussai, D Lissauer, D Carter
STUDY QUESTION: Does administration of recombinant human granulocyte colony stimulating factor (rhG-CSF) in the first trimester improve pregnancy outcomes, among women with a history of unexplained recurrent pregnancy loss? SUMMARY ANSWER: rhG-CSF administered in the first trimester of pregnancy did not improve outcomes among women with a history of unexplained recurrent pregnancy loss. WHAT IS KNOWN ALREADY: The only previous randomized controlled study of granulocyte colony stimulating factor in recurrent miscarriage in 68 women with unexplained primary recurrent miscarriage found a statistically significant reduction in miscarriage and improvement in live birth rates...
February 18, 2019: Human Reproduction
Christopher R Sudfeld, Emily R Smith
Recent data from an individual patient data (IPD) meta-analysis of 17 randomized control trials including >100,000 women living in low- and middle-income countries found that multiple micronutrient supplementation (MMS) in pregnancy reduced the risk of low birth weight, preterm birth, and being born small for gestational age. Further, MMS reduced the risk of neonatal and infant mortality for females, and there was no evidence of increased risk among the 26 subgroups examined. The 2016 WHO antenatal care guidelines, which were released before the IPD meta-analysis, did not universally recommend MMS, noting: "There is some evidence of additional benefit … but there is also some evidence of risk...
February 15, 2019: Journal of Nutrition
Reem Hatamleh, Sanaa Abujilban, Asma'a Shaker AbdelMahdi AbuAbed, Sawsan Abuhammad
OBJECTIVE: This study aimed to examine the effectiveness of a childbirth preparation course on birth outcomes among nulliparous Jordanian women. DESIGN: A randomized control trial pre-test/post-test design was used to assess the effects of a childbirth preparation course conducted in a military hospital in Amman, Jordan from 1 July to 15 September 2016. A total of 133 low-risk nulliparous women were recruited and randomly assigned to either (1) a control group who received standard care in antenatal clinics or (2) an intervention group who received standard care in antenatal clinics as well as a childbirth preparation course specifically designed for the purpose of this study...
February 7, 2019: Midwifery
Aurélie Maiguy-Foinard, Bertrand Décaudin, Pierre Tourneux, Bernard Guillois, Thierry Blanc, Sophie Galène-Gromez, Morgane Masse, Pascal Odou, Fannette Denies, Benoît Dervaux, Alain Duhamel, Laurent Storme
BACKGROUND: Catheter-related bacteremia (CRB) is the most frequent nosocomial infection in neonatal intensive care unit (NICU) patients, especially in very low-birth-weight infants. Administration of injectable drugs in premature newborn infants has many particularities and several types of infusion incidents have been reported. The Edelvaiss® Multiline NEO device is a novel multi-lumen access infusion device adapted to the specificities of infusion in neonatology. This multicenter, randomized, controlled study was therefore designed to determine whether or not Edelvaiss® Multiline NEO reduces the risk of CRB in preterm newborn infants in an NICU...
February 11, 2019: Trials
Lía Ornat, Vanesa Alonso-Ventura, Juan Bueno-Notivol, Peter Chedraui, Faustino R Pérez-López
OBJECTIVE: To compare the effect of misoprostol combined with a cervical single or double-balloon catheter versus misoprostol alone for labor induction of singleton pregnancies with an unfavorable cervix. METHODS: Systematic review and meta-analysis of randomized controlled trials (RCTs) regarding the comparison of two schemes for labor induction of singleton cephalic pregnancies with a Bishop score ≤7 and no contraindication for vaginal delivery. Six research databases were searched for articles published in all languages up to 10 May 2018 comparing misoprostol (oral or vaginal) in combination with a cervical placed single or double balloon catheter versus misoprostol treatment alone...
February 10, 2019: Journal of Maternal-fetal & Neonatal Medicine
Brenda S Lessen Knoll, Tipawan Daramas, Victoria Drake
OBJECTIVE: To evaluate the effect of the Premature Infant Oral Motor Intervention (PIOMI) on preterm newborns' feeding efficiency and rates of improvement across Days 1, 3, and 5 of oral feeding in a Thai NICU. DESIGN: Randomized controlled trial. SETTING: A 20-bed special neonatal ward and 8-bed NICU in urban Thailand. PARTICIPANTS: Stable newborns (N = 30) born between 26 and 34 weeks postmenstrual age (PMA) without comorbidities...
February 2, 2019: Journal of Obstetric, Gynecologic, and Neonatal Nursing: JOGNN
Vivienne Souter, Ian Painter, Kristin Sitcov, Aaron B Caughey
BACKGROUND: A growing body of evidence supports improved or not worsened birth outcomes with non-medically indicated induction of labor at 39 weeks compared to expectant management. This evidence includes two recent randomized control trials. However, concern has been raised as to whether these studies are applicable to a broader US pregnant population. OBJECTIVE: Our goal was to compare outcomes for electively induced births at 39 weeks or beyond with those that were not electively induced...
January 29, 2019: American Journal of Obstetrics and Gynecology
Mike L T Berendsen, Christian Bjerregård Øland, Pauli Bles, Aksel Karl Georg Jensen, Poul-Erik Kofoed, Hilton Whittle, Charlotte De Bree, Mihai G Netea, Cesario Martins, Christine S Benn, Peter Aaby
Background and Hypothesis: Maternal priming might enhance the beneficial nonspecific effects (NSEs) of live measles vaccination (MV). Children with a bacillus Calmette-Guérin (BCG) vaccine scar have a lower mortality rate than those without a scar that is not explained by protection against tuberculosis. We examined the hypothesis that BCG scarring would have a stronger effect on a child if the mother also had a BCG scar. Methods: In a randomized controlled trial (RCT) of early MV in children aged 4...
February 3, 2019: Journal of the Pediatric Infectious Diseases Society
Kannan Sridharan, Gowri Sivaramakrishnan, Steve Kanters
BACKGROUND: Data regarding the relative safety profile of anti-malarial drugs in pregnancy is sparse mainly limited by the absence of head-to-head clinical trials. The present study is a network meta-analysis of safety of anti-malarial drugs used to treat malaria in pregnant women. METHODS: A thorough literature search using the search strategy "Malaria [tiab] AND (Pregnant [tiab] OR Pregnancy [tiab])" was carried out for either randomized controlled trials or prospective cohort studies in pregnant malarial women prescribed any of the recommended anti-malarial drugs by World Health Organization (WHO) and that have reported adverse pregnancy outcomes such as miscarriage, still birth, and neonatal deaths...
January 28, 2019: International Journal of Risk & Safety in Medicine
A Pels, N A Mensing van Charante, C A Vollgraff Heidweiller-Schreurs, J Limpens, H Wolf, M A de Boer, W Ganzevoort
OBJECTIVE: Cardiotocography (CTG) is an important tool for fetal surveillance in severe early-onset fetal growth restriction (FGR). Assessment of the CTG is usually performed visually (vCTG). However, it is suggested that computerized analysis of the CTG (cCTG) including short term variability (STV) could more accurately detect fetal compromise. The objective of this study was to systematically review the literature on the association between cCTG and perinatal outcome and the comparison of cCTG with vCTG...
January 22, 2019: European Journal of Obstetrics, Gynecology, and Reproductive Biology
Michelle Mears, Michelle Yang, Bradley A Yoder
BACKGROUND:  Pulmonary hypertension with left ventricular dysfunction commonly occurs in congenital diaphragmatic hernia (CDH). Milrinone, a phosphodiesterase-III inhibitor with lusitropic and vasodilator effects, is used in up to 30% of CDH infants across the United States. No randomized trials have tested the efficacy or safety of milrinone in CDH neonates. STUDY DESIGN:  We performed a paired retrospective analysis of CDH infants to assess the efficacy of milrinone treatment ( N  = 24 pairs)...
February 1, 2019: American Journal of Perinatology
Tanveer Bashir, Srinivas Murki, Sai Kiran, Venkat Kallem Reddy, Tejo Pratap Oleti
BACKGROUND: With increasing use of nCPAP, the safety and comfort associated with nCPAP have come into the forefront. The reported incidence of nasal injuries associated with the use of nCPAP is 20% to 60%. A recent meta-analysis concluded that the use of nasal masks significantly decreases CPAP failure and the incidence of moderate to severe nasal injury and stress the need for a well powered RCT to confirm their findings. METHODS: In this Open label, 3 arms, sequential, stratified randomized controlled trial, we evaluated the incidence and severity of nasal injury at removal of nCPAP when using two different nasal interfaces and in three groups (i...
2019: PloS One
Shiqin Xu, Xiaofeng Shen, Shijiang Liu, Jianjun Yang, Xian Wang
BACKGROUND: Phenylephrine is the current "gold standard' vasopressor used to treat maternal hypotension in women undergoing cesarean delivery with spinal anesthesia. Since 2015, various studies have explored the use of norepinephrine to manage maternal hypotension. We conducted this systematic review and meta-analysis of available randomized controlled trials (RCTs) to compare the efficacy and safety of norepinephrine and phenylephrine for the prevention and treatment of maternal hypotension...
February 2019: Medicine (Baltimore)
Amanda Gwee, Noel Cranswick, Brendan McMullan, Elizabeth Perkins, Srinivas Bolisetty, Kaya Gardiner, Andrew Daley, Meredith Ward, Roberto Chiletti, Susan Donath, Rodney Hunt, Nigel Curtis
BACKGROUND: In adults, continuous infusions of vancomycin (CIV) are associated with earlier attainment of target drug concentrations, require fewer blood samples for monitoring, and may reduce drug toxicity. We aimed to determine, in young infants, if CIV or intermittent infusions of vancomycin (IIV) better achieves target vancomycin concentrations at the first steady-state level and to compare the frequency of drug-related adverse effects. METHODS: In a multicenter randomized controlled trial in 2 tertiary neonatal units over a 40-month period, young infants aged 0 to 90 days requiring vancomycin therapy for at least 48 hours were randomly assigned to CIV and IIV...
January 30, 2019: Pediatrics
Thomas P Bernardes, Eva F Zwertbroek, Kim Broekhuijsen, Corine Koopmans, Kim Boers, Michelle Owens, Jim Thornton, Maria van Pampus, Sicco Scherjon, Kedra Wallace, Josje Langenveld, Paul P van den Berg, Maureen Franssen, Ben W Mol, Henk Groen
BACKGROUND: Hypertensive disorders affect 3-10% of pregnancies. Delayed delivery carries maternal risks, while early delivery increases fetal risk so appropriate timing is difficult. OBJECTIVE: To compare immediate delivery and expectant management for prevention of adverse maternal and neonatal outcomes in hypertensive disease in pregnancy. SEARCH STRATEGY: We searched CENTRAL, PubMed, MEDLINE and SELECTION CRITERIA: Randomized controlled trials comparing immediate delivery to expectant management in women presenting with mild gestational hypertension or pre-eclampsia from 34 weeks of gestation...
January 29, 2019: Ultrasound in Obstetrics & Gynecology
Adam K Lewkowitz, Anjlie Gupta, Laura Simon, Bethany A Sabol, Carrie Stoll, Emily Cooke, Roxanne A Rampersad, Methodius G Tuuli
OBJECTIVE: To assess the effect of intravenous versus oral iron on hematologic indices and clinical outcomes for iron-deficiency anemia (IDA) in pregnancy. STUDY DESIGN: Searches in Ovid Medline, Embase, SCOPUS, Cochrane Database, and identified randomized-controlled trials comparing intravenous to oral iron for treating IDA in pregnancy. Primary outcomes were maternal hematologic indices at delivery. Secondary outcomes were blood transfusion, cesarean delivery, neonatal outcomes, and medication reactions...
January 28, 2019: Journal of Perinatology: Official Journal of the California Perinatal Association
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