Dataset Information

Effects of Delayed Cord Clamping on 4-Month Ferritin Levels, Brain Myelin Content, and Neurodevelopment: A Randomized Controlled Trial.

ABSTRACT:

Objective

To evaluate whether placental transfusion influences brain myelination at 4 months of age.

Study design

A partially blinded, randomized controlled trial was conducted at a level III maternity hospital in the US. Seventy-three healthy term pregnant women and their singleton fetuses were randomized to either delayed umbilical cord clamping (DCC, >5 minutes) or immediate clamping (ICC, <20 seconds). At 4 months of age, blood was drawn for ferritin levels. Neurodevelopmental testing (Mullen Scales of Early Learning) was administered, and brain myelin content was measured with magnetic resonance imaging. Correlations between myelin content and ferritin levels and group-wise DCC vs ICC brain myelin content were completed.

Results

In the DCC and ICC groups, clamping time was 172 ± 188 seconds vs 28 ± 76 seconds (P < .002), respectively; the 48-hour hematocrit was 57.6% vs 53.1% (P < .01). At 4 months, infants with DCC had significantly greater ferritin levels (96.4 vs 65.3 ng/dL, P = .03). There was a positive relationship between ferritin and myelin content. Infants randomized to the DCC group had greater myelin content in the internal capsule and other early maturing brain regions associated with motor, visual, and sensory processing/function. No differences were seen between groups in the Mullen testing.

Conclusion

At 4 months, infants born at term receiving DCC had greater ferritin levels and increased brain myelin in areas important for early life functional development. Endowment of iron-rich red blood cells obtained through DCC may offer a longitudinal advantage for early white matter development.

Trial registration

ClinicalTrials.gov: NCT01620008.

SUBMITTER: Mercer JS

PROVIDER: S-EPMC6259583 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background: Recently, the literature suggested that placental transfusion facilitated by delayed cord clamping (DCC), besides having benefits on hematological parameters, might improve the infants' brain development. Objective: The present review primarily evaluates the Ages and Stages Questionnaire (ASQ) total score mean difference (MD) at long-term follow-up (≥4 months) comparing DCC (>90 or >180 s) to early cord clamping (ECC). Secondary aims consisted of evaluating the ASQ domains' MD and the results obtained from other methods adopted to evaluate the infants' neurodevelopment. Methods: MEDLINE, Scopus, Cochrane, and ClinicalTrials.gov databases were searched (up to 2nd November 2020) for systematic review and meta-analysis. All randomized controlled trials (RCTs) of term singleton gestations received DCC or ECC. Multiple pregnancies, pre-term delivery, non-randomized studies, and articles in languages other than English were excluded. The included studies were assessed for bias and quality. ASQ data were pooled stratified by time to follow up. Results: This meta-analysis of 4 articles from 3 RCTs includes 765 infants with four-month follow-up and 672 with 12 months follow-up. Primary aim (ASQ total score) pooled analysis was possible only for 12 months follow-up, and no differences were found between DCC and ECC (MD 1.1; CI 95: -5.1; 7.3). DCC approach significantly improves infants' communication domains (MD 0.6; CI 95: 0.1; 1.1) and personal-social assessed (MD 1.0; CI 95: 0.3; 1.6) through ASQ at 12 months follow-up. Surprisingly, the four-month ASQ personal social domain (MD -1.6; CI 95: -2.8; -0.4) seems to be significantly lower in the DCC group than in the ECC group. Conclusions: DCC, a simple, non-interventional, and cost-effective approach, might improve the long-term infants' neurological outcome. Single-blinding and limited studies number were the main limitations. Further research should be performed to confirm these observations, ideally with RCTs adopting standard methods to assess infants' neurodevelopment. Trial registration: NCT01245296, NCT01581489, NCT02222805, NCT01620008, IRCT201702066807N19, and NCT02727517.

Project description:BackgroundDelayed cord clamping (DCC) results in decreased iron deficiency in infancy. The American College of Obstetrics and Gynecology has called for research on the optimal time to clamp the cord during cesarean deliveries (CD). Our objective was to conduct a pilot trial examining the safety of delayed cord clamping (DCC) for maternal-infant dyads during elective cesarean delivery (CD).MethodsWe enrolled 39 dyads [23 at 90 s, 16 at 120 s; (DCC Pilot)] between 10/2013 and 9/2014. We abstracted data from the electronic medical record (EMR) for historical controls (HC) birthing between 1/2012-6/2013 for whom DCC was not performed (n = 112).ResultsAvailable data for 37 mothers and 30 infants compared to HC revealed 174 (95% CI: 61-286) mL lower mean estimated maternal blood loss [(EBL) mean (SD) mL]: DCC Pilot 691(218) vs. HC 864(442), p = 0.003 and lower incidence of maternal transfusions, DCC Pilot 2.7% vs. HC 18.8%, p = 0.016. There was no significant between group difference between DCC Pilot and HC in other a priori definitions of excess maternal blood loss: a) EBL > 800 ml, 21.6% vs. 38.8%, p = 0.07 or b) post-op hgb/pre-op hgb < 80%, 16.7% vs. 20.6%, p = 0.81. There were also no statistically significant between group differences in rates of NICU admission DCC Pilot 8.1% vs. HC 7.1%, p = 1.0., but there was a higher rate of newborn cold stress or hypothermia ≤36.2 °C in study subjects, DCC Pilot 27.0% vs. HC 11.9%, p = 0.038.Prevalence of newborn anemia was decreased [DCC pilot 3.3% (1 of 30) vs. HC 40.0% (4 of 10 infants with data), p = 0.012. No infants were polycythemic.ConclusionsThese pilot data suggest cord clamping can be delayed to 120 s during elective CD without increased risk of excessive maternal blood loss. More aggressive prevention of infant heat loss may be warranted. A randomized trial to evaluate long-term maternal and infant outcomes is indicated.Trial registrationClinical trials.gov, NCT02229162; registered: 1 September, 2014.