scholarly journals 250 RANDOMIZED PLACEBO-CONTROLLED TRIAL OF THYROXINE ADMINISTRATION TO INFANTS OF LESS THAN 30 WEEKS GESTATIONAL AGE IN RELATION TO MORTALITY AND MORBIDITY

1994 ◽  
Vol 36 (1) ◽  
pp. 44A-44A
Author(s):  
Aleid G Van Wassenaer ◽  
Joke H Kok ◽  
Jan J M De Vijlder
Author(s):  
Elizabeth B. Ausbeck ◽  
Phillip Hunter Allman ◽  
Jeff M. Szychowski ◽  
Akila Subramaniam ◽  
Anup Katheria

Objective The aim of the study is to describe the rates of neonatal death and severe neonatal morbidity in a contemporary cohort, as well as to evaluate the predictive value of birth gestational age (GA) and birth weight, independently and combined, for neonatal mortality and morbidity in the same contemporary cohort. Study Design We performed a secondary analysis of an international, multicenter randomized controlled trial of delayed umbilical cord clamping versus umbilical cord milking in preterm infants born at 23 0/7 to 31 6/7 weeks of gestation. The current analysis was restricted to infants delivered <28 weeks. The primary outcomes of this analysis were neonatal death and a composite of severe neonatal morbidity. Incidence of outcomes was compared by weeks of GA, with planned subanalysis comparing small for gestational age (SGA) versus non-SGA neonates. Multivariable logistic regression was then used to model these outcomes based on birth GA, birth weight, or a combination of both as primary independent predictors to determine which had superior ability to predict outcomes. Results Of 474 neonates in the original trial, 180 (38%) were included in this analysis. Overall, death occurred in 27 (15%) and severe morbidity in 139 (77%) neonates. Rates of mortality and morbidity declined with increasing GA (mortality 54% at 23 vs. 9% at 27 weeks). SGA infants (n = 25) had significantly higher mortality compared with non-SGA infants across all GAs (p < 0.01). There was no difference in the predictive value for neonatal death or severe morbidity between the three prediction options (GA, birth weight, or GA and birth weight). Conclusion Death and severe neonatal morbidity declined with advancing GA, with higher rates of death in SGA infants. Birth GA and birth weight were both good predictors of outcomes; however, combining the two was not more predictive, even in SGA infants. Key Points


2020 ◽  
Author(s):  
Zalfa Kanaan ◽  
Coralie Bloch-Queyrat ◽  
Marouane Boubaya ◽  
Vincent Lévy ◽  
Pascal Bolot ◽  
...  

Abstract BACKGROUND Lung recruitment at birth has been advocated as an effective method of improving the respiratory transition at birth. Sustained inflations (SI) and dynamic positive end-expiratory pressure (PEEP) were assessed in clinical and animal studies to define the optimal level. Our working hypothesis was that very low gestational age infants (VLGAI) < 32 weeks’ gestation require an individualized lung recruitment based on combining both manoeuvers. METHODS Between 2014 and 2016, 91 and 72 inborn VLGAI, requiring a respiratory support beyond a continuous positive airway pressure (CPAP) = 5 cmH2O, were enrolled before and after introducing these manoeuvers based on progressive increase in SI up to 15 seconds, with simultaneous gradual increase in PEEP up to 15 cmH2O, according to the cardiorespiratory response. Retrospective comparisons of the incidence of mechanical ventilation (MV) < 72h of life, short-term and before discharge morbidity were then performed. RESULTS Among extremely low gestational age infants (ELGAI) < 29 weeks’ gestation, the following outcomes decreased significantly: intubation (90% to 55%) and surfactant administration (54% to 12%) in the delivery room, MV (92% to 71%) and its mean duration < 72h of life (45h to 13h), administration of a 2nd dose of surfactant (35% to 12%) and postnatal corticosteroids (52% to 19%), and the rate of bronchopulmonary dysplasia (23 to 5%). Among VLGAI, all of these results were also significant. Neonatal mortality and morbidity were not different. CONCLUSIONS In our setting, combining two individualized lung recruitment maneuvers at birth was feasible and may be beneficial on short-term and before discharge pulmonary outcomes. A randomized controlled trial is needed to confirm these results.


2020 ◽  
Author(s):  
Zalfa Kanaan ◽  
Coralie Bloch-Queyrat ◽  
Marouane Boubaya ◽  
Vincent Lévy ◽  
Pascal Bolot ◽  
...  

Abstract BACKGROUND Lung recruitment at birth has been advocated as an effective method of improving the respiratory transition at birth. Sustained inflations (SI) and dynamic positive end-expiratory pressure (PEEP) were assessed in clinical and animal studies to define the optimal level. Our working hypothesis was that very low gestational age infants (VLGAI) < 32 weeks’ gestation require an individualized lung recruitment based on combining both manoeuvers. METHODS Between 2014 and 2016, 91 and 72 inborn VLGAI, requiring a respiratory support beyond a continuous positive airway pressure (CPAP) = 5 cmH2O, were enrolled before and after introducing these manoeuvers based on progressive increase in SI up to 15 seconds, with simultaneous gradual increase in PEEP up to 15 cmH2O, according to the cardiorespiratory response. Retrospective comparisons of the rate of mechanical ventilation (MV) < 72h of life, short-term and before discharge morbidity were then performed. RESULTS Among extremely low gestational age infants (ELGAI) < 29 weeks’ gestation, the following outcomes decreased significantly: intubation (90% to 55%) and surfactant administration (54% to 12%) in the delivery room, MV (92% to 71%) and its mean duration < 72h of life (45h to 13h), administration of a 2nd dose of surfactant (35% to 12%) and postnatal corticosteroids (52% to 19%), and the rate of bronchopulmonary dysplasia (23 to 5%). Among VLGAI, all of these results were also significant. Neonatal mortality and morbidity were not different. CONCLUSIONS In our setting, combining two individualized lung recruitment maneuvers at birth was feasible and may be beneficial on short-term and before discharge pulmonary outcomes. A randomized controlled trial is needed to confirm these results.


2019 ◽  
Author(s):  
Zalfa Kanaan ◽  
Coralie Bloch-Queyrat ◽  
Marouane Boubaya ◽  
Vincent Lévy ◽  
Pascal Bolot ◽  
...  

Abstract BACKGROUND Lung recruitment at birth has been advocated as an effective method of improving the respiratory transition at birth. Sustained inflations (SI) and dynamic positive end-expiratory pressure (PEEP) were assessed in clinical and animal studies to define the optimal level. Our working hypothesis was that very low gestational age infants (VLGAI) < 32 weeks’ gestation require an individualized lung recruitment based on combining both manoeuvers. METHODS Between 2014 and 2016, 100 and 102 inborn VLGAI were enrolled before and after introducing these manoeuvers based on progressive increase in SI up to 15 seconds, with simultaneous gradual increase in PEEP up to 15 cmH2O, according to the cardiorespiratory response. Retrospective comparisons of the rate of mechanical ventilation (MV) < 72h of life, short- and mid-term morbidity were then performed. RESULTS Among extremely low gestational age infants (ELGAI) < 29 weeks’ gestation, MV and its mean duration < 72h of life, consumption of a 2 nd dose of surfactant, and postnatal corticosteroids decreased significantly from 92 to 71%, 42 to 12h, 35 to 12%, and 49 to 24%, respectively. Among VLGAI, most of these results, and the rate of bronchopulmonary dysplasia (decreasing from 14 to 6%), were significant after a multivariate analysis. Neonatal mortality and morbidity were not different. CONCLUSIONS In our setting, combining two individualized lung recruitment maneuvers at birth was feasible and may be beneficial on short- and mid-term pulmonary outcomes, especially in ELGAI < 29 weeks’ gestation. A randomized controlled trial is needed to confirm these results.


Author(s):  
Salma Younes ◽  
Muthanna Samara ◽  
Rana Al-Jurf ◽  
Gheyath Nasrallah ◽  
Sawsan Al-Obaidly ◽  
...  

Preterm birth (PTB) and early term birth (ETB) are associated with high risks of perinatal mortality and morbidity. While extreme to very PTBs have been extensively studied, studies on infants born at later stages of pregnancy, particularly late PTBs and ETBs, are lacking. In this study, we aimed to assess the incidence, risk factors, and feto-maternal outcomes of PTB and ETB births in Qatar. We examined 15,865 singleton live births using 12-month retrospective registry data from the PEARL-Peristat Study. PTB and ETB incidence rates were 8.8% and 33.7%, respectively. PTB and ETB in-hospital mortality rates were 16.9% and 0.2%, respectively. Advanced maternal age, pre-gestational diabetes mellitus (PGDM), assisted pregnancies, and preterm history independently predicted both PTB and ETB, whereas chromosomal and congenital abnormalities were found to be independent predictors of PTB but not ETB. All groups of PTB and ETB were significantly associated with low birth weight (LBW), large for gestational age (LGA) births, caesarean delivery, and neonatal intensive care unit (NICU)/or death of neonate in labor room (LR)/operation theatre (OT). On the other hand, all or some groups of PTB were significantly associated with small for gestational age (SGA) births, Apgar <7 at 1 and 5 minutes and in-hospital mortality. The findings of this study may serve as a basis for taking better clinical decisions with accurate assessment of risk factors, complications, and predictions of PTB and ETB.


Hypertension ◽  
2021 ◽  
Vol 78 (Suppl_1) ◽  
Author(s):  
Rugina I Neuman ◽  
Willy Visser ◽  
Jan H Danser

Low soluble Fms-like tyrosine kinase (sFlt-1) has been reported in women with suspected or confirmed preeclampsia (PE) coincidentally using proton pump inhibitors (PPIs), suggesting a role for these agents as potential treatment for PE. Here, we examined whether administration of omeprazole to women with PE could acutely reduce their circulating levels of sFlt-1 or enhance their placental growth factor (PlGF) concentrations. We performed a randomized controlled trial in which women (≥ 18 years) with confirmed preeclampsia and a gestational age between 20 +0 and 34 +6 weeks were allocated to receive 40mg omeprazole once daily or no omeprazole. Blood was collected at baseline and days 1,2,4,8 followed by twice-weekly until delivery. Primary outcome was specified as the difference in sFlt-1 or PlGF 4 days after omeprazole initiation compared to the non-omeprazole group. Secondary outcomes were defined as between-group differences in longitudinal course of sFlt-1 and PlGF and pregnancy outcomes. Between Dec 2018 and June 2021, 50 women with PE were randomized, of which 40 women remained pregnant after 4 days. Mean maternal age was 30 years, and median gestational age was 31 weeks. Baseline sFlt-1 levels did not differ between non-omeprazole (n=20) and omeprazole group (n=20) (10743 vs. 7110pg/mL, p=0.11), neither did the levels of PlGF (p=0.14). After 4 days, sFlt-1 levels remained similar in women receiving omeprazole compared to women not receiving omeprazole (8364 vs. 13017pg/mL, p=0.14), and the same was true for PlGF (90 vs. 55pg/mL, p=0.14). Using linear mixed models, no difference in longitudinal course of sFlt-1 or PlGF could be attributed to the treatment group, when adjusted for baseline values and GA at enrollment (p=0.47). Women receiving omeprazole had a similar length of pregnancy compared with those not receiving this drug (median 15 vs. 14 days, p=0.70). Except for a higher neonatal intubation rate in the non-omeprazole group (31% vs 4%, p=0.02) there were no differences in maternal/perinatal complications between the two groups. Our findings suggest that daily administration of 40mg in women with PE do not alter their circulating levels of sFlt-1 and PlGF, arguing against a role for this drug as a potential treatment for this syndrome.


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Ihab Hassan Abdel Fattah ◽  
Mohamed Mahmoud Abdel Allim ◽  
MortadaElsayed Ahmed ◽  
Yasmeen Ahmed Mohamed Taha

Abstract Background Preterm delivery with its associated morbidity and mortality still represents one of the major unsolved problems in Obstetrics. In PPROM, there is an increased incidence of preterm delivery which represents a life threatening situation. It has been calculated that the mean duration of PROM pregnancies is 37 weeks, so premature birth defined as delivery before 37 week of gestation, is the leading cause of perinatal mortality and short and long term fetal morbidity. Obviously, preterm deliveries represent a problem because of the severe neonatal complications that often occur afterwards. These complications are worse for the smaller newborn with earlier gestational age. These complications include respiratory distress syndrome, intraventricular hemorrhage, sepsis and necrotizing enterocolitis. Objective The present study aims to investigate the effect of 17-OH progesterone on primegravida and the possible change in the premature delivery rates and other pregnancy outcomes and complications regarding its use. Methods The current research is a randomized controlled study was conducted at Obstetric outpatient clinic of Ain Shams University Maternity Hospital and involved 80 pregnant admitted to assess the efficacy of intramuscular progesterone compared to placebo therapy in decreasing the rate of preterm birth in women with PPROM pregnancy, selected on basis being with age between 18-35 years, carrying Singleton pregnancy, at gestational age between24-34 weeks. Results The present study provides no evidence that 17OHP-C is beneficial in women with PROM. Although the trial turned out to be underpowered for the primary outcome, it had reasonable statistical power for the prespecified secondary outcomes, which allowed us to conclude that 17OHP-C does not prolong pregnancy or reduce perinatal morbidity after PROM. Preterm PROM is a frequently encountered obstetric diagnosis, with improved neonatal outcomes when an uninfected mother is able to continue her pregnancy for a longer duration to reach a more advanced gestational age. Conclusion Compared placebo with intramuscular 17-OHPC in women with prelabour rupture of membranes. Pregnancy is associated with lower percentage of preterm labour, fewer NICU admissions in 17 OHPC.


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