Respiratory Distress Syndrome in Premature Infants Clinical Trial
Official title:
Does a Repeat Course of Antenatal Corticosteroids in Pregnant Women With Preterm Premature Rupture of Membranes Decrease Neonatal Morbidity?
Verified date | January 2024 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care unit (NICU) and the overall neonatal morbidity associated with this condition.
Status | Terminated |
Enrollment | 33 |
Est. completion date | December 20, 2023 |
Est. primary completion date | December 20, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Maternal age = 18 years - Preterm premature rupture of membranes, demonstrated clinically by speculum exam - Cervical dilation visually = 5cm on sterile speculum exam - Planned delivery at John Sealy Hospital (JSH) - Gestational age of membrane rupture and initiation of first course of antenatal corticosteroids between 23 5/7 - 32 5/7 weeks - Planned pregnancy continuation with no indication for delivery for at least 7 days Exclusion Criteria: - Maternal age > 50 years - Gestational age < 23 5/7 weeks or > 32 5/7 weeks - Known major congenital abnormalities, aneuploidy, or genetic syndrome - Intrauterine fetal demise - Any indication for expedited delivery - Maternal chorioamnionitis - Known allergy or adverse reaction to corticosteroids |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Medical Branch in Galveston | Galveston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston |
United States,
Atarod Z, Taghipour M, Roohanizadeh H, Fadavi S, Taghavipour M. Effects of single course and multicourse betamethasone prior to birth in the prognosis of the preterm neonates: A randomized, double-blind placebo-control clinical trial study. J Res Med Sci. 2014 Aug;19(8):715-9. — View Citation
Brookfield KF, El-Sayed YY, Chao L, Berger V, Naqvi M, Butwick AJ. Antenatal corticosteroids for preterm premature rupture of membranes: single or repeat course? Am J Perinatol. 2015 May;32(6):537-44. doi: 10.1055/s-0034-1396690. Epub 2014 Dec 29. — View Citation
Elimian A, Verma U, Canterino J, Shah J, Visintainer P, Tejani N. Effectiveness of antenatal steroids in obstetric subgroups. Obstet Gynecol. 1999 Feb;93(2):174-9. doi: 10.1016/s0029-7844(98)00400-1. — View Citation
Elimian A, Verma U, Visintainer P, Tejani N. Effectiveness of multidose antenatal steroids. Obstet Gynecol. 2000 Jan;95(1):34-6. doi: 10.1016/s0029-7844(99)00471-8. — View Citation
Gyamfi-Bannerman C, Son M. Preterm premature rupture of membranes and the rate of neonatal sepsis after two courses of antenatal corticosteroids. Obstet Gynecol. 2014 Nov;124(5):999-1003. doi: 10.1097/AOG.0000000000000460. — View Citation
Mazumder P, Dutta S, Kaur J, Narang A. Single versus multiple courses of antenatal betamethasone and neonatal outcome: a randomized controlled trial. Indian Pediatr. 2008 Aug;45(8):661-7. — View Citation
National Institutes of Health Consensus Development Panel. Antenatal corticosteroids revisited: repeat courses - National Institutes of Health Consensus Development Conference Statement, August 17-18, 2000. Obstet Gynecol. 2001 Jul;98(1):144-50. doi: 10.1016/s0029-7844(01)01410-7. — View Citation
Practice bulletins No. 139: premature rupture of membranes. Obstet Gynecol. 2013 Oct;122(4):918-930. doi: 10.1097/01.AOG.0000435415.21944.8f. — View Citation
Wijnberger LD, Mostert JM, van Dam KI, Mol BW, Brouwers H, Visser GH. Comparison of single and repeated antenatal corticosteroid therapy to prevent neonatal death and morbidity in the preterm infant. Early Hum Dev. 2002 Apr;67(1-2):29-36. doi: 10.1016/s0378-3782(01)00248-1. — View Citation
Yang SH, Choi SJ, Roh CR, Kim JH. Multiple courses of antenatal corticosteroid therapy in patients with preterm premature rupture of membranes. J Perinat Med. 2004;32(1):42-8. doi: 10.1515/JPM.2004.007. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Labor latency | time from diagnosis of PPROM from admission until delivery of neonate or until completion of the study | time from admission to delivery up to one year, or through study completion | |
Other | Infectious morbidities | Chorioamnionitis will be defined as at least one temperature elevation above 38°C combined with at least two of the following signs: maternal or fetal tachycardia, uterine tenderness, foul smelling vaginal discharge, white blood count > 18,000. Postpartum endometritis will be defined as postpartum temperature elevation above 38°C without other localizing sources of infection and with either uterine tenderness or foul-smelling lochia. | time from admission until maternal discharge from the hospital and up until 6 weeks postpartum, or through study completion | |
Primary | Length of stay in the neonatal intensive care unit (NICU) | expressed in days | daily from birth of infant up to one year | |
Secondary | Composite neonatal morbidity | defined as = 1 of the following: RDS (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (requirement for oxygen support at 30 days of life), severe IVH (grades III or IV), periventricular leukomalacia, blood culture-proven sepsis, necrotizing enterocolitis, or perinatal death (stillbirth or death before neonatal hospital discharge) | assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first | |
Secondary | Duration of oxygen and ventilatory support | Amount of time in days from birth that the infant requires supplemental oxygen of any form, including nasal cannula, positive airway pressure, or ventilatory support | assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first | |
Secondary | Development of Respiratory Distress Syndrome (RDS) | Will be quantified as either present or absent. RDS defined as: compatible symptoms with radiographic evidence of hyaline membrane disease or respiratory insufficiency of prematurity requiring ventilatory support for = 24 hrs | assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first | |
Secondary | Grade III or IV intraventricular hemorrhage (IVH) | Will be quantified as either present or absent. Grade III IVH defined as ventricles enlarged by accumulating blood. Grade IV IVH defined as bleeding extending into brain matter around the ventricles. | assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first | |
Secondary | Neonatal Sepsis | confirmed by culture in the first 72 hours of life | daily up to 72 hours of life | |
Secondary | Necrotizing enterocolitis (NEC) stage 2 or 3 | Will be quantified as either present or absent. Stage 2 NEC will be defined as mild to moderate systemic illness, absent bowel sounds, abdominal tenderness, pneumatosis intestinalis or portal venous gas, metabolic acidosis, decreased platelets. Stage 3 NEC will be defined as severely ill, marked distention, signs of peritonitis, hypotension, metabolic & respiratory acidosis, disseminated intravascular coagulopathy, pneumoperitoneum if bowel perforation present. | assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first | |
Secondary | Perinatal death | defined as stillbirth or death before neonatal discharge | assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first |
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