Comparison of Prophylaxis and Rescue Treatment With Curosurf in Neonates Less than 30 Weeks' Gestation: A Randomized Trial

PEDIATRICS ◽  
1993 ◽  
Vol 92 (6) ◽  
pp. 768-774 ◽  
Author(s):  
Johannes Egberts ◽  
J. Peter de Winter ◽  
Gunnar Sedin ◽  
Martin J.K. de Kleine ◽  
Ulf Broberger ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Gestational Age ◽  
Periventricular Leukomalacia ◽  
Ductus Arteriosus ◽  
Expectant Management ◽  
Supplemental Oxygen ◽  
Preterm Neonates ◽  
Transcutaneous Oxygen ◽  
Prophylaxis Group ◽  
Rescue Treatment

Objective. The aim of this randomized clinical trial was to evaluate the immediate effects of prophylactic administration of Curosurf and to compare outcomes after prophylactic or expectant management. Study design. Porcine surfactant (Curosurf, 200 mg/kg body weight) was administered intratracheally within 10 minutes of birth to preterm neonates with a gestational age of 26 to 29 weeks (n = 75); rescue-eligible neonates (n = 72) were initially subjected to a sham maneuver. The primary end points of the trial, evaluated at the age of 6 hours, were to obtain (1) a 40% decrease in the ratio between transcutaneous oxygen tension (tcPo2) (kPa) and fraction of inspired oxygen (Fio2), and (2) a 50% decrease in the incidence of radiologically verified respiratory distress syndrome (RDS). After 6 to 24 hours, a similar dose of surfactant was given to the neonates of both the prophylaxis and the rescue-eligible group, if they needed mechanical ventilation with an Fio2 ≥ 0.6. Results. At 6 hours the prophylaxis group had, in comparison with the rescue-eligible group, significantly higher tcPo2/Fio2 ratios (mean ± SD: 39.7 ± 15.3 vs 28.1 ± 18.1; P < .001) and less severe RDS by radiological scoring (χ2 = 14.9; P = .005). Severe RDS was present in 19% of the prophylactically treated neonates versus 32% in the rescue-eligible group (P < .05). The prophylaxis group needed shorter periods of Fio2 > 0.40 than the rescueeligible neonates (P < .01), and eight neonates of the prophylaxis group (11%) versus 23 of the rescue-eligible group (32%) qualified for rescue treatment with surfactant in the interval 6 to 24 hours (P < .01). There were no differences in the incidence or severity of pneumothorax, pulmonary interstitial emphysema, cerebral hemorrhage, periventricular leukomalacia, patent ductus arteriosus, in the duration of mechanical ventilation or time in supplemental oxygen, or in mortality. Conclusions. Subgroup analysis revealed (1) that administration of corticosteroids reduced the risk of developing neonatal RDS as effectively as did surfactant prophylaxis at birth, and (2) that prophylaxis was effective especially in neonates with gestational age <28 weeks or birth weight <1000 g, in male neonates, and in neonates who had received no antenatal treatment with corticosteriods. Our data indicate that prophylactic treatment with surfactant should be considered in high-risk neonates fulfilling these latter criteria.

scholarly journals The Management of Myelomeningocele Study: Short-Term Neonatal Outcomes

2020 ◽  
Vol 47 (12) ◽  
pp. 865-872 ◽  
Author(s):  
Natalie E. Rintoul ◽  
Roberta L. Keller ◽  
William F. Walsh ◽  
Pamela K. Burrows ◽  
Elizabeth A. Thom ◽  
...  
Keyword(s):  
New England ◽  
Gestational Age ◽  
Periventricular Leukomalacia ◽  
Ductus Arteriosus ◽  
Outcome Data ◽  
Neonatal Outcomes ◽  
Increased Risk ◽  
Significant Difference ◽  
The Impact ◽  
Prenatal Surgery

<b><i>Introduction:</i></b> The Management of Myelomeningocele Study was a multicenter randomized trial to compare prenatal and standard postnatal repair of myelomeningocele (MMC). Neonatal outcome data for 158 of the 183 randomized women were published in <i>The New England Journal of Medicine</i> in 2011. <b><i>Objective:</i></b> Neonatal outcomes for the complete trial cohort (<i>N</i> = 183) are presented outlining the similarities with the original report and describing the impact of gestational age as a mediator. <b><i>Methods:</i></b> Gestational age, neonatal characteristics at delivery, and outcomes including common complications of prematurity were assessed. <b><i>Results:</i></b> Analysis of the complete cohort confirmed the initial findings that prenatal surgery was associated with an increased risk for earlier gestational age at birth. Delivery occurred before 30 weeks of gestation in 11% of neonates that had fetal MMC repair. Adverse pulmonary sequelae were rare in the prenatal surgery group despite an increased rate of oligohydramnios. There was no significant difference in other complications of prematurity including patent ductus arteriosus, sepsis, necrotizing enterocolitis, periventricular leukomalacia, and intraventricular hemorrhage. <b><i>Conclusion:</i></b> The benefits of prenatal surgery outweigh the complications of prematurity.

Oral acetaminophen administration for patent ductus arteriosus (PDA) closure in preterm neonates

2021 ◽  
Vol 43 (3) ◽  
pp. 254-259
Author(s):  
Mahmood Samadi ◽  
Zahra Nabaee ◽  
Manizheh Mostafagharebaghi ◽  
Majid Mahalei ◽  
Elham Sheykhsaran ◽  
...  
Keyword(s):  
Patent Ductus Arteriosus ◽  
Gestational Age ◽  
Statistical Significance ◽  
Ductus Arteriosus ◽  
Preterm Neonates ◽  
Term Infants ◽  
Treatment Data ◽  
Kolmogorov Smirnov ◽  
Study Population ◽  
Patent Ductus

Background: Patent Ductus Arteriosus (PDA) is considered one of the most prevalent types of congenital heart disease. The closure of the ductus arteriosus physiologically occurs at the first 48-72 hours after the birth in healthy term infants. Different causes can result in the pathological opening of ductus arteriosus. This study aims to investigate the effect of oral acetaminophen on the closure of PDA in preterm neonates. Methods: The present study is a trial without control. Forty-five preterm neonates with a gestational age of <32 weeks were studied. Acetaminophen was orally administered with a dose of 10mg/kg every 6 hours for three days. Closure of ductus arteriosus was considered as the success of treatment. Data were analyzed using SPSS 15. Data were reported as )frequency-percent) and mean ± SD. To evaluate the normal distribution of data, we used a Kolmogorov-Smirnov test. Statistical significance was defined as P<0.05. Results: The study population consisted of 20 male and 25 female infants with the mean gestational age of 28.95 ± 1.66 weeks. Cesarean-born infants and vaginal-born infants consisted 17.8% and 82.2% of the study population, respectively. The proportion of PDA closure after administration of oralacetaminophen was 82.3%. Conclusion: The current study indicates that oral acetaminophen is highly effective in closing PDA. Considering its trivial side effects, it has the potency to be a convenient option for treating this condition.

Preterm Pulmonary Hemorrhage Is Associated with Multiple Births but Not with Intracytoplasmic Sperm Injection: A Cohort Study on Medical Records

2018 ◽  
Vol 35 (11) ◽  
pp. 1087-1092
Author(s):  
Stefanie Stierling ◽  
Ralf-Dieter Hilgers ◽  
Sonja Trepels-Kottek ◽  
Konrad Heimann ◽  
Thorsten Orlikowsky ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cohort Study ◽  
Gestational Age ◽  
Intracytoplasmic Sperm Injection ◽  
Medical Records ◽  
Ductus Arteriosus ◽  
Pulmonary Hemorrhage ◽  
Multiple Births ◽  
Preterm Neonates ◽  
Increased Risk

Objective Pulmonary hemorrhage (PH) is a severe complication in preterm neonates. This study aims to identify risk factors and comorbidities of PH. Study Design A single-center cohort study on medical records including all preterm neonates of <30 weeks' gestational age was conducted in the neonatal intensive care unit of Universitätsklinikum Aachen, Germany. The occurrence of PH served as a primary end point. Gestational age, birthweight, sex, multiple births, intracytoplasmic sperm injection (ICSI), intubation, surfactant, antenatal steroids, intraventricular hemorrhage (IVH), amniotic infection syndrome, and persistent ductus arteriosus were studied as risk factors. Results In this study, 344 preterm neonates were included, of whom 36 suffered from PH (10.5%). The mean time of the first occurrence was the third day of life (standard deviation [SD]: 1.2). On average, the patients suffered from 1.5 incidents (SD: 0.8) of PH, of whom 50% were severe. Preterm neonates born as multiples (95% confidence interval [CI]: 3.1, 26.9) and those who suffered from IVH (95% CI: 2.7, 18.9) had a significantly increased risk of PH. ICSI was not an independent risk factor. Conclusion PH is significantly associated with IVH and multiple births but not with ICSI. The identification of patients at risk allows to apply prophylactic strategies of ventilation and pharmacological treatment.

scholarly journals Value of transcranial ultrasound screening for the preterm in the neonatal ICU

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
S B Ali ◽  
A S Abdelrahman ◽  
M I Hassan
Keyword(s):  
Gestational Age ◽  
Imaging Modality ◽  
Periventricular Leukomalacia ◽  
Transcranial Ultrasound ◽  
Radiology Department ◽  
Preterm Neonates ◽  
Cranial Ultrasound ◽  
Ultrasound Screening ◽  
Agenesis Of Corpus Callosum ◽  
Neonatal Icu

Abstract Background preterm neonates less than 37 weeks of gestational age are more liable to hemorrhagic and ischemic brain lesions due to the immaturity of capillary bed, cerebral auto-regulation and vascular anastomosis, with consequent adverse outcome, poor cognitive development, and cerebral palsy. Cranial ultrasound is a safe imaging modality with no need to radiation exposure or sedation. Aim of the Work to evaluate the usefulness of universal cranial ultrasound screening in preterm neonates in the neonatal ICU with gestational age between 28 and 37 weeks to detect the different intra cranial pathologies in this pediatric group. Patients and Methods After taking approval by the Radiology Department Committee of the Faculty of Medicine, Ain shams University, the current study was performed on all preterm neonates (50) admitted to neonatal ICU in Ain shams hospital between 28 and 37 weeks of gestational age, between the third and seventh day of life, from July 1, 2017 to April 1, 2018 were included in the study. Results The study showed normal transcrainal ultrasound (72.0%), Germinal matrix hemorrhage (10.0%), Intraventricular hemorrhage (6.0%), Periventricular leukomalacia (6.0%), Congenital anomalies is Dandy walker malformation (2.0%), Chiari malformation (0.0%), Agenesis of corpus callosum (2.0%) and Porencephalic cyst (2.0%) of finding of ultrasound. Conclusion The importance of preterm screening by cranial ultrasound is sustained by the observation that most preterm neonates with abnormal CUS are usually asymptomatic. Only occasionally these patients develop symptoms.Linear high frequency probe of ultrasound was of great benefit in better visualization of anatomical details and mild pathological lesions.

scholarly journals Intraventricular hemorrhage in very low birth weight infants: associated risk factors and outcome in the neonatal period

1999 ◽  
Vol 54 (5) ◽  
pp. 151-154 ◽  
Author(s):  
Monique Catache Mancini ◽  
Naila Elias Barbosa ◽  
Débora Banwart ◽  
Sandra Silveira ◽  
José Luiz Guerpelli ◽  
...  
Keyword(s):  
Risk Factors ◽  
Mechanical Ventilation ◽  
Birth Weight ◽  
Low Birth Weight ◽  
Gestational Age ◽  
Intraventricular Hemorrhage ◽  
Very Low Birth Weight ◽  
Periventricular Leukomalacia ◽  
Associated Risk Factors ◽  
Length Of Hospitalization

Intraventricular hemorrhage (IVH) is a severe complication in very low birth weight (VLBW) newborns (NB). With the purpose of studying the incidence of IVH, the associated risk factors, and the outcomes for these neonates, we studied all the VLBW infants born in our neonatal unit. Birth weight, gestational age, presence of perinatal asphyxia, mechanical ventilation, length of hospitalization, apnea crisis, hydrocephalus, and periventricular leukomalacia were analyzed. The diagnosis of IVH was based on ultrasound scan studies (Papile's classification) performed until the tenth day of life and repeated weekly in the presence of abnormalities. Sixty-seven/101 neonates were studied. The mortality rate was 30.6% (31/101) and the incidence of IVH was 29.8% (20/67) : 70% grade I, 20% grade III and 10% grade IV. The incidence of IVH in NB <1,000 g was 53.8% (p = 0.035) and for gestational age <30 weeks was 47.3% (p = 0.04), both considered risk factors for IVH. The length of hospitalization (p = 0.00015) and mechanical ventilation (p = 0.038) were longer in IHV NB. The IVH NB had a relative risk of 2.3 of developing apnea (p = 0.02), 3.7 of hydrocephalus (p = 0.0007), and 7.7 of periventricular leukomalacia (p < 0.00001). The authors emphasize the importance of knowing the risk factors related to IVH so as to introduce prevention schemes to reduce IVH and to improve outcomes of affected newborns.

scholarly journals CYP2C9*2 is associated with indomethacin treatment failure for patent ductus arteriosus

2019 ◽  
Vol 20 (13) ◽  
pp. 939-946
Author(s):  
Sydney R Rooney ◽  
Elaine L Shelton ◽  
Ida Aka ◽  
Christian M Shaffer ◽  
Ronald I Clyman ◽  
...  
Keyword(s):  
Patent Ductus Arteriosus ◽  
Treatment Failure ◽  
Preterm Infants ◽  
Gestational Age ◽  
Genetic Factors ◽  
Ductus Arteriosus ◽  
Preterm Neonates ◽  
Multicenter Cohort Study ◽  
Patent Ductus ◽  
Indomethacin Treatment

Aims: To identify clinical andgenetic factors associated with indomethacin treatment failure in preterm neonates with patent ductus arteriosus (PDA). Patients & Methods: This is a multicenter cohort study of 144 preterm infants (22–32 weeks gestational age) at three centers who received at least one treatment course of indomethacin for PDA. Indomethacin failure was defined as requiring subsequent surgical intervention. Results: In multivariate analysis, gestational age (AOR 0.76, 95% CI 0.60–0.96), surfactant use (AOR 9.77, 95% CI 1.15–83.26), and CYP2C9*2 (AOR 3.74; 95% CI 1.34–10.44) were each associated with indomethacin failure. Conclusion: Age, surfactant use, and CYP2C9*2 influence indomethacin treatment outcome in preterm infants with PDA. This combination of clinical and genetic factors may facilitate targeted indomethacin use for PDA.

Comparison of Efficacy of Oral Ibuprofen versus Paracetamol for PDA Closure in Preterm Neonates

2021 ◽  
Vol 15 (8) ◽  
pp. 2529-2532
Author(s):  
Muhammad Arif ◽  
Asif Saleem Afridi ◽  
Farman Ali ◽  
Syed Ul Abrar Buneri ◽  
Muhammad Salman
Keyword(s):  
Mortality Rate ◽  
Gestational Age ◽  
Ductus Arteriosus ◽  
Adverse Outcomes ◽  
Preterm Neonates ◽  
Closure Rate ◽  
Cesarean Birth ◽  
Group I ◽  
Oral Ibuprofen ◽  
Group Ii

Objective: The aim of this study is to compare the efficacy of oral ibuprofen versus paracetamol for PDA closure in preterm neonates. Study Design: Randomized Control trial Place and Duration: The study was conducted at Neonatology department North West General Hospital, Peshawar for duration of three years from April 2018 to March 2021. Methods: Total one hundred and fifty preterm neonates were included in this study. Patients’ detailed demographics including gestational age, gender; birth and diameter were recorded after taking informed written consent from the parents. Patients were equally divided into two groups, I and II. Group I had 75 patients and received paracetamol for closure for patent ductus arteriosus and group II received oral ibuprofen for closure of PDA. Outcomes among both groups were calculated in terms of effectiveness, mortality and post-operative complications. Data was analyzed by SPSS 22.0 version. Results: Mean gestational age of the patients in group I was 29.12±7.44 weeks and in group II mean gestational age was 30.09±4.66 weeks. 45 (65%) male in group I and in group II 40 (53.3%) were male babies. Mean ductal diameter in group I was 3.02±1.13 and in group II mean diameter was 2.98±0.16 mm. In group I cesarean birth was found in 50 (66.7%) and in group II 48 (64%) cesarean birth was found. Mean duration of closure was lower in group I 4.24±1.03 days as compared to group II 5.01±0.03 days. PDA closure rate was higher in group I 62 (82.7%) and in group II its frequency was 58 (77.3%). Re-opening of ductus was found in 6 (8%) in group I and 8 (10.7%) in group II. Adverse outcomes were renal failure, hyperbilirubinemia and gastrointestinal bleeding among both groups. Mortality rate in ibuprofen group was higher 7 (9.3%) as compared to group I 4 (5.3%). Conclusion: We concluded in this study that the use of drug paracetamol is effective for the closure of PDA in preterm neonates as compared to oral ibuprofen with less adverse outcomes and mortality rate. Keywords: PDA, Neonates, Paracetamol, Ibuprofen, Complications, Mortality

Novel strategy to personalise use of ibuprofen for closure of patent ductus arteriosus in preterm neonates

2021 ◽  
pp. archdischild-2020-321381
Author(s):  
Samira Samiee-Zafarghandy ◽  
Tamara van Donge ◽  
Gerhard Fusch ◽  
Marc Pfister ◽  
George Jacob ◽  
...  
Keyword(s):  
Patent Ductus Arteriosus ◽  
Gestational Age ◽  
Ductus Arteriosus ◽  
Plasma Concentrations ◽  
Preterm Neonates ◽  
Pharmacokinetic Parameters ◽  
Therapeutic Drug ◽  
Population Pharmacokinetic ◽  
Target Exposure ◽  
Patent Ductus

ObjectiveExploration of a novel therapeutic drug monitoring (TDM) strategy to personalise use of ibuprofen for closure of patent ductus arteriosus (PDA) in preterm neonates.DesignProspective, single-centre, open-label, pharmacokinetics study in preterm neonates.SettingNeonatal intensive care unit at McMaster Children’s Hospital.PatientsNeonates with a gestational age ≤28+6 weeks treated with oral ibuprofen for closure of a PDA.MethodsPopulation pharmacokinetic parameters, concentration-time profiles and exposure metrics were obtained using pharmacometric modelling and simulation.Main outcome measureAssociation between ibuprofen plasma concentrations measured at various sampling time points on the first day of treatment and attainment of the target exposure over the first 3 days of treatment (AUC0–72h >900 mg·hour/L).ResultsTwenty-three preterm neonates (median birth weight 780 g and gestational age 25.9 weeks) were included, yielding 155 plasma ibuprofen plasma samples. Starting from 8 hours’ postdose on the first day, a strong correlation between ibuprofen concentrations and AUC0–72h was observed. At 8 hours after the first dose, an ibuprofen concentration >20.5 mg/L was associated with a 90% probability of reaching the target exposure.ConclusionWe designed a novel and practical TDM strategy and have shown that the chance of reaching the target exposure (AUC0–72h >900 mg·hour/L) can be predicted with a single sample collection on the first day of treatment. This newly acquired knowledge can be leveraged to personalise ibuprofen dosing regimens and improve the efficacy of ibuprofen use for pharmacological closure of a PDA.

Association of Surgical Necrotizing Enterocolitis and its Timing with Retinopathy of Prematurity

2021 ◽  
Author(s):  
Jennifer B. Fundora ◽  
Gil Binenbaum ◽  
Lauren Tomlinson ◽  
Yinxi Yu ◽  
Gui-shuang Ying ◽  
...  
Keyword(s):  
Necrotizing Enterocolitis ◽  
Gestational Age ◽  
Retinopathy Of Prematurity ◽  
Late Onset ◽  
Periventricular Leukomalacia ◽  
Ductus Arteriosus ◽  
Secondary Data ◽  
Postnatal Growth ◽  
Logistic Regression Models ◽  
Increased Risk

Objective The study aimed to determine the association of surgical necrotizing enterocolitis (NEC) and its timing, with the development and timing of retinopathy of prematurity (ROP). Study Design This was a secondary data analysis of 7,483 preterm infants from the Postnatal Growth and Retinopathy of Prematurity Study. Associations between infants with surgical NEC, early-onset surgical NEC (8–28 days), and late-onset surgical NEC (over 28 days) with ROP were evaluated by using multivariable logistic regression models, controlling for birth weight, gestational age, small for gestational age status, chronic lung disease, intraventricular hemorrhage, hydrocephalus, patent ductus arteriosus, and periventricular leukomalacia. Results Three hundred fifty-six (4.8%) infants had surgical NEC, with 56% having early surgical NEC. Infants with surgical NEC had a higher risk of any ROP and severe ROP (adjusted odds ratio [OR]: 2.7; 95% CI: 1.9–3.7) and 2.5 (95% CI: 1.9–3.3), respectively; p < 0.001) compared with infants without surgical NEC. Infants with early surgical NEC were at the highest risk of developing ROP and severe ROP (adjusted OR: 3.1 [95% CI: 2.1–4.8], and 3.3 [95% CI: 2.3–4.7] respectively, p < 0.001). Infants with late surgical NEC were also at increased risk of developing ROP and severe ROP (adjusted OR: 2.1 [95% CI: 1.3–3.4], and 1.9 [95% CI: 1.3–2.8] respectively, p < 0.001) compared with infants without surgical NEC. Conclusion Infants with surgical NEC, especially early surgical NEC, are at higher risk of ROP and severe ROP. Key Points

scholarly journals Doxapram Use for Apnoea of Prematurity in Neonatal Intensive Care

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
S. A. Prins ◽  
S. J. A. Pans ◽  
M. M. van Weissenbruch ◽  
F. J. Walther ◽  
S. H. P. Simons
Keyword(s):  
Intensive Care ◽  
Neonatal Intensive Care ◽  
Periventricular Leukomalacia ◽  
Ductus Arteriosus ◽  
Neonatal Morbidity ◽  
Preterm Neonates ◽  
Short Term ◽  
Prospective Trials ◽  
Care Outcome

Apnoea of prematurity is treated with noninvasive respiratory therapy and methylxanthines. For therapy unresponsive apnoea doxapram is often prescibed in preterm neonates. The duration, dosage and route of administration of doxapram together with its efficacy was evaluated in two Dutch neonatal intensive care. Outcome concerning short-term safety and neonatal morbidity were evaluated. During 5 years, 122 of 1,501 admitted newborns <32 weeks of gestational age received doxapram. 64.8% of patients did not need intubation after doxapram. 25% of treated neonates were <27 weeks of gestation. A positive response to doxapram therapy on apnoea was associated with longer duration of doxapram usage (P<0.001), lower mean doses (P<0.003), and less days of intensive care (median 33 versus 42 days;P<0.002). No patients died during doxapram therapy. Incidence of necrotizing enterocolitis, intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity, persistent ductus arteriosus, or worsening of pulmonary condition did not increase during doxapram therapy. Doxapram is frequently used for apnoea of prematurity, despite a lack of data on short-term efficacy and long-term safety. Until efficacy and safety are confirmed in prospective trials, doxapram should be used with caution.

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