shows the distribution of the 296 women who were admitted with preterm labor and who were screened for eligibility for this study. All additional analyses were performed on the 72 randomly assigned subjects.
Flow of women admitted for preterm labor between August 2003 and November 2004, including participants in the cord-clamping study.
There were 7 protocol violations. Six occurred in the DCC group with cord-clamping time ranging between 2 and 18 seconds instead of 30 seconds. These were mainly as a result of miscommunication at births. There was 1 protocol violation in the ICC group when a physician delayed clamping for 25 seconds as a result of a misunderstanding of the protocol. All infants remained in their assigned groups for analyses.
shows no significance difference in maternal demographics, clinical characteristics, and medical management.
Maternal Demographics, Clinical Characteristics, and Prenatal Medical Management
shows no significant difference in the demographic and clinical characteristics of the study infants. Cord-clamping time was significantly different per protocol; infants in the DCC group had significantly longer cord-clamping times (32 ± 13 vs 7 seconds ± 4; P < .001). All other neonatal variables, including those used for safety (1- and 5-minute Apgar scores, temperature on admission, serum bilirubin levels), were not significantly different between the groups.
Neonatal Demographic, Clinical, and Safety Variables
shows that there were no significant differences in the incidence of death or BPD, NEC, amount of blood loss and transfusion, and ROP between the 2 groups. There were also no differences between the infants in surfactant use (27 vs 24), days of ventilation (39 vs 35), and oxygen use at 28 days (11 vs 13) for the ICC and DCC groups, respectively.
Neonatal Morbidities, Blood Loss, and Transfusions
shows that infants in the DCC group had less IVH (five [14%] vs 13 [36%]; P = .03) during the first 28 days in the NICU. The incidence of IVH was equally divided between the stratified groups (<28 weeks = 10; 28 ± weeks = 8), although the majority occurred in infants <30 weeks gestation (data not shown). In the infants <28 weeks, 7 (47%) of the 15 infants in the ICC group had IVH vs 3 (21%) of the 14 infants in the DCC group (not significant), whereas in those born after 28 weeks, 6 (29%) of 21 in the ICC group and 2 (10%) of 22 in the DCC group had IVH.
IVH and LOS in Study Infants
Similar number of infants in each group received low-dose indomethacin for IVH prophylaxis within the first 24 hours. All of the infants between 24 and 27 weeks had indomethacin, whereas 59% and 62% received indomethacin in the DCC and ICC groups, respectively. The grade 4 IVH was not seen until day of life 12. One infant in the DCC group with IVH was a protocol violation and had ICC.
We compared all infants with IVH (n = 18) with all infants without IVH (n = 54). Infants with IVH had shorter time between birth and cord clamping (13 vs 22 seconds; P = .04) and were less likely to have had a cesarean delivery (three [17%] vs 15 [48%]; P = .03). There was no relationship between IVH and sepsis.
shows that infants in the DCC group were less likely to have blood culture-proven sepsis during the NICU stay (3% vs 22%; P = .03). Six cases of confirmed sepsis occurred in the 24- to 27-week-old infants, whereas 3 were in infants 28 to 31 weeks. Of the 9 infants who had LOS, 7 (78%) occurred between 11 and 18 days of age. Infants with sepsis had lower initial hematocrit levels at birth (48 ± 6 vs 42 ± 5; P = .03) even when controlling for gestational age.
Analyses by gender revealed that male infants had an advantage with DCC for IVH, sepsis, and NEC. Gender effects are shown in .
Gender Differences in IVH, LOS, and NEC Among Infants With ICC and DCC
There were no adverse events or deaths in the DCC group. Three infants died in the ICC group. The causes of death included fulminating NEC (two) and terminal respiratory failure with probable sepsis syndrome.
Additional multivariate analyses were performed to evaluate the association of cord clamping with IVH and LOS. The impact of cord-clamping group on IVH was evaluated adjusting for gestational age and cesarean section. The final model indicated that the IVH rate was >3 times higher in the ICC group (odds ratio [OR]: 3.5, 95% confidence interval [CI] 1.1–11.1). A similar model for LOS adjusted for gestational age showed that infants in the DCC group were less likely to have sepsis (OR: 0.10, 95% CI: 0.01–0.84).
The eligible women not enrolled during the study period did not differ from the 72 randomly assigned participants on any of the demographic variables. They differed from randomly assigned women only in antenatal steroid use (87% vs 100%; P = .01), premature rupture of membranes in hours (20 ± 36 vs 40 ± 45; P = .01), and cesarean section rate (64% vs 40%; P = .01). Infants of eligible women not enrolled differed from study infants only on admission temperature (96.3 ± 1.4 vs 97 ± 1.4; P = .01). There was no significant difference in the overall incidence of IVH (25% vs 18%; P = .35) or sepsis (3% vs 8%; P = .42) between the subjects and the infants of eligible women not enrolled.