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PDA Treatment in Preemies NOT helpful
 

Benitz WE.  Treatment of Patent Ductus Arteriosus in premature infants: time to accept the null hypothesis?  J Perinatol (April 2010); 30: 241-52.    PDF of Article

Medical and surgical interventions are widely used to close a persistently patent ductus arteriosus in preterm infants. Objective evidence to support these practices is lacking, causing some to question their usage. Emerging evidence suggests that treatments that close the patent ductus may be detrimental. This review examines the history of and evidence underlying these treatments. Neither individual trials, pooled data from groups of randomized-controlled trials, nor critical examination of the immediate consequences of treatment provide evidence that medical or surgical closure of the ductus is beneficial in preterm infants. These conclusions are supported by sufficient evidence. Neither continued routine use of these treatments nor additional clinical trials using similar designs seems to be justified. A definitive trial, comparing current standard management with novel strategies not primarily intended to achieve ductal closure, may be necessary to resolve doubts regarding the quality or conduct of prior studies.

Comments:
Every now and again I run across an article in the literature that makes me question whether any of my previously-held beliefs in neonatology are correct.  This was just such an article.  Who would have thought that after 30+ years where closure of the PDA by medication or surgery was standard practice for premature babies, we would be challenged to consider convincing evidence that there is NO demonstrable benefit (and significant risks) from these practices.  This paper presents an elaborate meta-analysis of 49 randonized controlled trials of ductal closure with nearly 5000 subjects. Dr Benitz concluded that there was "no evidence that this widespread practice benefits its recipients.  Absence of evidence of benefit is not an artifact of lack of trials, inadequate statistical power, or noncompliance with trial design.  On the contrary, the available evidence indicates that later treatment of fewer infants produces better outcomes." 

This study is not the only review that found no evidence of long-term benefit from closure of the PDA in premature babies.  There have been several previous Cochrane reviews of this topic with similar findings.  See:
Ibuprofen for PDA : http://www2.cochrane.org/reviews/en/ab003481.html
Prophylactic Surgical Ligation : http://www2.cochrane.org/reviews/en/ab006181.html
Indomethacin for Asymptomatic PDA : http://www.nichd.nih.gov/cochrane/Cooke/COOKE.HTM
Prophylactic Indomethacin treatment:  http://www2.cochrane.org/reviews/en/ab000174.html
Surgical Vs Medical Treatment:  http://www2.cochrane.org/reviews/en/ab003951.html

 In light of these findings, I will be much more selective about which babies in my practice warrant treatment to close the PDA. either by medical treatment or surgery.  Nemerofsky et al suggested that we should refrain from treating a PDA in all infants > 1 KG, and defer treatment of PDA until at least the second week of life in smaller infants.  I suppose that might be a good initial strategy, but I would hope that future studies would be able to better define a sub-group of premature infants who are likely to benefit from PDA closure, and what the optimal time for treatment would be. 

 Andy Kairalla

 

Additional Comments

Date: 20 Apr 2010
Time: 11:13:41

Finally good Evidence to suggest NOT every premiee the PDA needs to be closed early agressively by medical or surgical means. In my limited practice experience of 19 years I recall closing the PDA only 5 times in babies more than 27-28 weeks gestation or 1000 gram birth weight. Physiologically every baby is born with a Ductus - I do not feel the need to close it unless the neonate it affecting the respiratory status and the neonate continues to ventilator dependent. Thank you Dr. Benitz!!

UserName: Ravi Agarwal
Institution: Fort Walton Beach Medical Center
telephone: 8504960855
email: neodoc1@yahoo.com

Date:            11 May 2010
Time:            12:54 AM

Echoing Andy Kairalla’s thoughts in article review 11-016 (April, 2010), it seems it may
be easier to hug Jello than to know for sure what, if anything, should be done to nudge 
closure of the preterm PDA. Hamrick and Hansmann’s article replays the cellular 
mechanisms involved in physiologic closure of the DA and provides augmenting discussion
focusing on the role of the platelet in ductal closure. The authors delineate current 
treatment options, including surgery, BNP and NT-pro-BNP therapy, and COX inhibition. 
Finally, they add their voices to the idea of developing a PDA staging system, based on 
clinical and echocardiologic criteria, designed to identify those infants most likely 
to benefit from specific treatment. 

Hamrick and Hansmann conclude that closure of the preterm PDA, either by COX inhibition 
or surgical ligation, is currently justified only by the reduction in severe IVH with 
prophylactic administration of indomethacin and, potentially, the reduction in NEC 
with prophylactic surgical ligation; however, given the risks of either therapy and the 
high rate of spontaneous closure, these prophylactic strategies cannot be recommended 
for all preterm newborns. Treatment strategies for the symptomatic PDA may be justified 
for select patients.

UserName:        Alta Kendall
UserEmail:       alta@telebyte.com
UserTel:         360-434-0945
UserHOSP:        Tacoma General Hospital


 

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