Low-Dose Indomethacin and Prevention of Intraventricular Hemorrhage: A Multicenter Randomized Trial

PEDIATRICS ◽  
1994 ◽  
Vol 93 (4) ◽  
pp. 543-550
Author(s):  
Laura R. Ment ◽  
Richard A. Ehrenkranz ◽  
Charles C. Duncan ◽  
David T. Scott ◽  
Kenneth J.W. Taylor ◽  
...  
Keyword(s):  
Birth Weight ◽  
Low Birth Weight ◽  
Patent Ductus Arteriosus ◽  
Intraventricular Hemorrhage ◽  
Low Dose ◽  
Very Low Birth Weight ◽  
Ductus Arteriosus ◽  
Trend Test ◽  
Cranial Ultrasound ◽  
Patent Ductus

Objectives. Parenchymal involvement of intraventricular hemorrhage (IVH) is a major risk factor for neurodevelopmental handicap in very low birth weight neonates. Previous trials have suggested that indomethacin would lower the incidence and severity of IVH in very low birth weight neonates. Methods. We enrolled 431 neonates of 600- to 1250-g birth weight with no evidence for IVH at 6 to 11 hours of age in a prospective, randomized, placebo-controlled trial to test the hypothesis that low-dose indomethacin (0.1 mg/kg intravenously at 6 to 12 postnatal hours and every 24 hours for two more doses) would lower the incidence and severity of IVH. Serial cranial ultrasound examinations and echocardiographs were performed. Results. There were no differences in the birth weight, gestational age, sex, Apgar scores, and percent of neonates treated with surfactant between the indomethacin and placebo groups. Within the first 5 days, 25 (12%) indomethacin-treated and 40 (18%) placebo-treated neonates developed IVH (P = .03, trend test). Only one indomethacin-treated patient experienced grade 4 IVH compared with 10 placebo-treated neonates (P = .01). Sixteen indomethacin-treated neonates and 29 control neonates died (P = .08); there was a difference favoring indomethacin with respect to survival time (P = .06). Eighty-six percent of all neonates had a patent ductus arteriosus on the first postnatal day; indomethacin was associated with significant ductal closure by the fifth day of life (P < .001). There were no differences in adverse events attributed to indomethacin between the two treatment groups. Conclusions. Low-dose prophylactic indomethacin significantly lowers the incidence and severity of IVH, particularly the severe form (grade 4 IVH). In addition,indomethacin closes the patent ductus arteriosus and is not associated with significant adverse drug events in very low birth weight neonates.

scholarly journals Role of Sequential Functional Echocardiography in Predicting Clinically Apparent Patent Ductus Arteriosus in Preterm Very Low Birth Weight Newborns-An Observational Study

2020 ◽  
Author(s):  
Anchala Bhardwaj ◽  
ARVIND SAILI ◽  
Dinesh Kumar Yadav ◽  
Ajay Kumar
Keyword(s):  
Birth Weight ◽  
Low Birth Weight ◽  
Patent Ductus Arteriosus ◽  
Left Atrial ◽  
Very Low Birth Weight ◽  
Ductus Arteriosus ◽  
Preterm Neonates ◽  
Predictive Utility ◽  
Patent Ductus

Abstract Background The management of patent ductus arteriosus in preterm neonates continues to be a topic of discussion and controversy. Prolonged ductal patency in preterm neonates has been associated with significant short and long term morbidities and with increased mortality however, policy of routine treatment of all during neonatal period has failed to show significant improvement in long term outcome. Echocardiography has emerged as a promising modality to screen the newborns at risk of adverse effects of ductal shunting. This helps in identifying PDAs that require treatment to ultimately prevent unnecessary therapy or delay of necessary therapy. There are multitude of studies that have evaluated large number of echocardiographic markers for their predictive utility but only few have included all ductal markers together in a single study. The reported sensitivity (26-100%) and specificity (6-100%) of echocardiographic markers vary over a wide range. Thus, this study was planned with an aim to assess the predictive utility of all available ductal markers and their added advantage of having all over few ones in clinically apparent PDA in preterm VLBW newborns.Methods It was an observational prospective study conducted in tertiary care NICU at Lady Hardinge Medical College, Delhi. Fifty preterm very low birth weight (VLBW) newborns underwent four sequential Echo scans within first 72 hrs; first scan within 12 hours then at 24 hrs ,48 hrs and 72 hrs of age and were monitored clinically for the signs of PDA up to two weeks of life or discharge whichever comes later.Results The Ductal diameter, pulsatile ductal flow pattern, Left pulmonary artery (LPA) velocity, Left atrial to aortic width (La/Ao) ratio, Left atrial volume index (LAVI), Left ventricle to aortic width (Lv/Ao) ratio, E/A ratio and Left ventricular output/superior vena caval (LVO/SVC) flow ratio predicted clinically apparent PDA during first 72 hours of life.Conclusion This study provides insights into the predictive utility of other ductal echo markers along with the routinely measured conventional ones during first 72 hours of life in preterm VLBW newborns.

Neurodevelopmental Outcome at 36 Months' Corrected Age of Preterm Infants in the Multicenter Indomethacin Intraventricular Hemorrhage Prevention Trial

PEDIATRICS ◽  
1996 ◽  
Vol 98 (4) ◽  
pp. 714-718 ◽  
Author(s):  
Laura R. Ment ◽  
Betty Vohr ◽  
William Oh ◽  
David T. Scott ◽  
Walter C. Allan ◽  
...  
Keyword(s):  
Birth Weight ◽  
Low Birth Weight ◽  
Intraventricular Hemorrhage ◽  
Maternal Education ◽  
Low Dose ◽  
Very Low Birth Weight ◽  
Cranial Ultrasound ◽  
The Mean ◽  
English Monolingual

Objectives. Low-dose indomethacin has been shown to prevent intraventricular hemorrhage (IVH) in very low birth weight neonates, and long-term neurodevelomental follow-up data are needed to validate this intervention. We hypothesized that the early administration of low-dose indomethacin would not be associated with adverse cognitive outcome at 36 months' corrected age (CA). Methods. We enrolled 431 neonates of 600 to 1250 g birth weight with no IVH at 6 to 12 hours in a randomized, prospective trial to determine whether low-dose indomethacin would prevent IVH. A priori, neurodevelopmental follow-up examinations, including the Stanford-Binet Intelligence Scale and Peabody Picture Vocabulary Test-Revised, and standard neurologic examinations were planned at 36 months' CA. Results. Three hundred eighty-four of the 431 infants survived (192 [92%] of 209 infants receiving indomethacin versus 192 [86%] of 222 infants receiving saline), and 343 (89%) children were examined at 36 months' CA. Thirteen (8%) of the 166 infants who received indomethacin and 14 (8%) of 167 infants receiving the placebo were found to have cerebral palsy. There were no differences in the incidence of deafness or blindness between the two groups. For the 248 English-monolingual children for whom IQ data follow, the mean gestational age was significantly younger for the infants who received indomethacin than for those who received the placebo. None of the 115 infants who received indomethacin was found to have ventriculomegaly on cranial ultrasound at term, compared with 5 of 110 infants who received the placebo. The mean ± SD Stanford-Binet IQ score for the 126 English-monolingual children who had received indomethacin was 89.6 ± 18.92, compared with 85.0 ± 20.79 for the 122 English-monolingual children who had received the placebo. Although maternal education was strongly correlated with Stanford-Binet IQ at 36 months' CA, there was no difference in educational levels between mothers of the infants receiving indomethacin and the placebo. Conclusions. Indomethacin administered at 6 to 12 hours as prophylaxis against IVH in very low birth weight infants does not result in adverse cognitive or motor outcomes at 36 months' CA.

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