There is no evidence to support the use of prophylactic surgical ligation of the patent ductus arteriosus (PDA) in the management of the preterm infants.
The ductus arteriosus is a blood vessel that is open during fetal life and connects blood flow from the vessel that supplies blood to the lungs to the major vessel that supplies blood to the body (the aorta). This blood vessel can stay open after birth leading to a condition called patent ductus arteriosus (PDA). PDA is one of the most common cardiac conditions in babies who are born very early (premature) and can lead to significant complications and death. Prophylactic (very early) closure of the ductus arteriosus (within 72 hours after birth) can be achieved medically or surgically. Llittle is known about the effectiveness and safety of very early surgical closure (ligation). The review found that surgical ligation in preterm infants reduced the risk of severe necrotizing enterocolitis (NEC), a gastrointestinal disease that mostly affects premature infants involving infection and inflammation of the bowel (intestine); however, early surgical ligation did not decrease the risk of death, chronic lung disease and other major complications of preterm infants. In view of the lack of significant benefit and growing data suggesting the potential harm of such treatment modality, current evidence does not support the use of early surgical ligation of PDA in the management of preterm infants.
Prophylactic surgical ligation of the PDA did not decrease mortality or BPD in ELBW infants. A significant reduction of stage II or III NEC was noted. Based on the current evidence, the high rate of spontaneous closure, availability of effective safe medical therapies, and the potential short and long-term complications of surgical ligation, the use such prophylactic surgical therapy is not indicated in the management of the preterm infants.
Patent ductus arteriosus (PDA) is associated with increased mortality and morbidity in preterm infants. Prophylactic indomethacin results in the reduction in significant PDA, need for surgical ligation, severe intraventricular hemorrhage and serious pulmonary hemorrhage without modifying long-term neurosensory outcomes. Little is known about the effectiveness and safety of prophylactic surgical closure of the PDA in extremely low birth weight (ELBW) infants.
To determine the effect of prophylactic surgical ligation of the PDA on mortality and morbidities of preterm infants less than 1000 g at birth as compared to no prophylaxis or prophylaxis with cyclooxygenase inhibitors.
We searched MEDLINE (1966 to December 2006), EMBASE (1980 to December 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2006), and abstracts of annual meetings of the Society for Pediatric Research (1995 to 2006).
This search was updated in March 2010.
Randomized or quazi-randomised controlled trials that enrolled infants ≤ 28 weeks gestation or ≤ 1000 g at birth who were on assisted ventilation and/or supplemental oxygen without clinical signs of hemodynamic significant PDA were considered. Trials addressing prophylactic surgical ligation of the PDA (i.e. procedure done during the first 72 hours of life) versus no intervention or cyclooxygenase inhibitor prophylaxis were included.
We used the standard methods of the Cochrane Neonatal Review Group. For dichotomous outcomes, relative risk (RR) and its associated confidence interval were calculated. For continuous outcomes, treatment effect was expressed as mean difference and its calculated standard deviation.
Only one eligible study that enrolled 84 ELBW infants was identified. Prophylactic surgical ligation of the PDA resulted in a statistically significant reduction of severe stage II or III necrotizing enterocolitis (NEC) [RR 0.25, 95% CI (0.08,0.83), p value 0.02, NNT 5]. The study found no statistically significant difference in mortality, severe grade III and IV intraventricular hemorrhage (IVH), BPD, and retinopathy of prematurity (ROP).