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Three Part Question

In a [preterm with symptomatic PDA], is [surgery or medical treatment] is effective in [controlling symptoms]

Clinical Scenario

in our tertiary neonatal unit, we had a preterm baby, who was born at 26 weeks. we had difficulty in weaning from ventilation as she had symptomatic PDA. we tried with indomethacin twice but we could not help her. once we have done the ligation, she came off the ventilator very soon after the surgery. then we wondered about the best initial treatment for PDA.

Search Strategy

medline(1966 - june2005), cochrane reviews ( issue 4 2005)
all trials involving preterms with symptomatic PDA and comparing surgical with medical treatment as initial treatment

Search Outcome

in medline, 11 out of 32 studies were relevant to the 3 part question
in cochrane reviews, 1 out of 10 was relevant.

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
M Malviya, A Ohlsson, S Shah march 2003 canada	systematic review of 1 RCT	systematic review (1b)	Mortality during stay, CLD, NEC, IVH, high creatinine level, sepsis, Lenth of hospital stay	The study found no statistically significant difference between surgical closure and indomethacin treatment in mortality during hospital stay, chronic lung disease, other bleeding, necrotizing enterocolitis, sepsis, creatinine level, or intraventricular hemorrhage. There was a statistically significant increase in the surgical group in incidence of pneumothorax [RR 2.68 (95% CI 1.45, 4.93); RD 0.25 (95% CI 0.11, 0.38); NNH 4 (95% CI 3, 9)] and retinopathy of prematurity grade III and IV [RR 3.80 (95% CI 1.12, 12.93); RD 0.11 (95% CI 0.02, 0.20), NNH 9 (95% CI 5, 50] compared to the indomethacin group. There was as expected a statistically significant decrease in failure of ductal closure rate in the surgical group as compared to the indomethacin group: [RR 0.04 (95% CI 0.01, 0.27); RD -0.32 (95% CI -0.43, -0.21), NNT 3 (95% CI 2, 4)].	intervention was not blinded as one of it was surgery.Postnatal age at which babies were randomized to surgical ligation or indomethacin was not clear
Little DC, Pratt TC, Blalock SE, Krauss DR, Cooney DR, Custer MD. march 2003 USA	212 preterm infants with PDA, been reviewed for complications for indomethacin	multicase review ( level 3b)	lenth of stay, NEC, BUN increase, failure of ductal closure, sepsis, IVH, Intestinal complications	One hundred sixty-seven babies (79%) received indomethacin, closing the PDA in 88 cases (53%, recurrence = 47%). Indomethacin complications (73%) included thrombocytopenia (36%), BUN increase (31%), sepsis (30%), oliguria (25%), hyponatremia (25%), IVH (16%), pulmonary interstitial emphysema (11%), NEC (8%), intestinal perforation (4%), and bleeding (3%). Seventy-seven babies (36%) required operations (92% in the NICU) performed by pediatric surgeons	not a proper study to compare the therapeutic intervention

Comment(s)

the systematic review of one RCT clearly shows that there is statistically signicant increase in surgical treatment for closure of ductus as compared to indomethacin. even in the multicase review, it stressed the same. but there are insufficient data to suggest that there are less complications with surgical treatment than medical treatment.

Clinical Bottom Line

though the surgical treatment offers complete cure, the data regarding net benefit are insufficient to make a choice between surgical ligation or medical treatment with indomethacin for initial treatment of symptomatic PDA infants

References

1. M Malviya, A Ohlsson, S Shah Surgical versus medical treatment with cyclooxygenase inhibitors for symptomatic patent ductus arteriosus in preterm infants cochrane review march 21 2003, issue 3
2. little DC, Pratt TC, Blalock SE, Krauss DR, Cooney DR, Custer MD. Patent ductus arteriosus in micropreemies and full-term infants: the relative merits of surgical ligation versus indomethacin treatment. journal of paediatric surgery march 2003 38(3) 492-6