RBC aggressive transitions Unassisted in extremely young infants

Toddlers underwent a red blood cell transfusion strategy for anemia in the multicenter TOP test.

At approximately 2 years of age, infants had similar levels of either death or survival but with neurodevelopmental impairment (i.e., mental retardation, cerebral palsy, hearing loss, or vision loss) whether randomly to higher or lower hemoglobin thresholds for transmission in the neonatal intensive care unit (NICU) shortly after birth (50.1% vs. 49.8%, altered RR 1.00, 95% CI 0.92–1.10).

The individual components of mortality (16.2% vs. 15.0%) and neurodevelopmental impairment (39.6% vs. 40.3%) did not differ between the higher and lower hemoglobin strategies, respectively, according to a group led by Haresh Kirpalani, MD, MSc, of Children. Philadelphia Hospital.

“Furthermore, there was no evidence that the effects of the referral strategy on primary outcome varied by location, birth weight group, or gender,” the authors wrote in an New England Journal of Medicine.

Transmission algorithms tested in the test were consistent with those used in conventional use, since the restriction strategy still kept hemoglobin levels within accepted ranges. clinical, they noted.

“This could be one of the most important studies in our field over the past decades. Ever since I was a medical student, we have debated whether hemoglobin levels were higher and pre- improved aggressive transmission techniques for young babies in the NICUs, “said Lance Prince, MD, PhD, of Stanford University School of Medicine and Lucford Packard Stanford Children ‘s Hospital in California.

The Prince suggested that, unlike previous studies providing mixed results, TOP kept study groups reliably separated because the group had pre-transfusion hemoglobin levels with a higher threshold of 1.9 g / dL. on average during the treatment period, as well as more solutions per child. (average 6.2 vs 4.4).

“However, this paper clearly suggests that allowing lower hemoglobin levels in those very severe infants (and therefore lower numbers / exposures to blood tolerance) is safe and ongoing. to similar long – term outcomes, “he said MedPage today in an email.

Another group had reported worse outcomes in newborns experiencing preoperative bleeding. The evidence generally indicates limited mobility safety for adults in a variety of situations.

The TOP test was conducted at 19 centers participating in the Eunice Kennedy Shriver National Institute for Child Health and Human Development Neonatal Research Network.

Eligible infants were those born with a very low birth weight of 1 kg (2.20 lbs) or less and a gestational age of 22 to 29 weeks. All were randomized within 48 hours of delivery to red cell transfusion at higher or lower hemoglobin thresholds to 36 weeks of age or postmenopausal release (whichever occurred first) .

There were 1,824 babies in TOP (average birth weight 756 g [1.67 lbs], meaning gestational age 25.9 weeks). Similar baseline features between groups.

Kirpalani and his colleagues reported that undiagnosed survival rates without adverse events (28.5% vs 30.9%) and adverse events (22.7% vs. 21.7%) did not differ between the liberal and trans-liberal strategies. put limited.

In particular, the main endpoint of the trial could be assessed for 92.8% of the group at 22-26 months of age due to protocol violations or other reasons.

“For ethical reasons, we could not hold back non-algorithmic referrals (i.e., those that were not performed according to the randomly assigned transmission algorithm), so there was a break rate there is an imbalance, with more non – algorithmic solutions in the group with a lower threshold, reflecting the dissatisfaction of some physicians with hemoglobin levels in the lowest range, “the TOP team warned.

“Nevertheless, the number of fractures was low and that did not stop a good separation between groups in average hemoglobin levels,” Kirpalani and colleagues continued.

TOP findings are also consistent with the smaller ETTNO test that recently reported no benefit to a liberal transition approach for very small infants in the NICU.