TABLE 8.
Key Outcomes for Comparison 3: CCM Versus ECC
| Outcomes | No. Participants (Studies) Follow-up | Certainty of the Evidence | Relative Effect (95% CI) | RD/MD (95% CI) | I2 |
|---|---|---|---|---|---|
| Neonatal outcomes | |||||
| Survival to discharge from hospital | 60 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b,c,d | RR: 1.00 (0.94 to 1.07) | RD: 0.00 (−0.06 to 0.06) | Not estimable |
| Severe IVH: ultrasound diagnosis grades III, IV | 60 (1 RCT) | ⊕⊝⊝⊝ Very lowa,c,d,e | RR: 0.33 (0.01 to 7.87) | RD: −0.03 (−0.12 to 0.05) | Not estimable |
| CLD: oxygen at 36 wk PMA | 60 (1 RCT) | ⊕⊝⊝⊝ Very lowf | RR: 1.00 (0.07 to 15.26) | RD: 0.00 (−0.09 to 0.09) | Not estimable |
| NEC (Bell’s stage ≥II or any grade47; requiring surgery) | 60 (1 RCT) | ⊕⊝⊝⊝ Very lowa,c,d,f | RR: 0.50 (0.05 to 5.22) | RD: −0.03 (−0.14 to 0.08) | Not estimable |
| Peak Hb concentrations within the first 24 h after birth | 0 (0 studies) | — | — | Not estimable | Not estimable |
| Peak Hct within the first 24 h after birth | 60 (1 RCT) | ⊕⊕⊝⊝ Lowa,c,d,g | Continuous outcome | MD: 3.34 (0.60 to 6.08) | Not estimable |
| Peak Hb concentrations within 7 d after birth | 0 (0 studies) | — | — | Not estimable | Not estimable |
| Peak Hct within 7 d after birth | 0 (0 studies) | — | — | Not estimable | Not estimable |
| Hyperbilirubinemia (treated by phototherapy) | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Infant outcome | |||||
| Moderate to severe neurodevelopmental impairment in early childhood | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Cerebral palsy in early childhood | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Significant mental developmental delay in early childhood | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Legal blindness in early childhood (<20/200 visual acuity) | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Hearing deficit in early childhood (aided or <60 dB on audiometric testing) | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Maternal outcomes | |||||
| PPH (clinically estimated blood loss of ≥500 mL) | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Maternal death or severe morbidity | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Severe PPH (blood loss ≥1000 mL) | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Use of therapeutic uterotonic agents | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Blood transfusion (maternal) | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Manual removal of the placenta | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Additional treatment of PPH (uterine tamponade, embolization) | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Postpartum infection | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
CLD, chronic lung disease; Hb, hemoglobin; Hct, hematocrit; PMA, postmenstrual age; PPH, postpartum hemorrhage; —, not applicable; ⊕, positive; ⊝, negative.
Some concerns because of lack of blinding. No downgrade, because this outcome unlikely to be influenced by lack of blinding. This is a borderline decision.
No death in either of the intervention groups. Effect could range from clinically meaningful reduction to clinically meaningful increase in survival. Downgrade by 2 for imprecision.
Only 1 study, so not possible to assess inconsistency. No downgrade.
Only 1 single-center study with 60 participants. Impairs generalizability. Downgrade by 1 for indirectness.
Effect could range from very large reduction to very large increase in outcome. Only 1 event. Downgrade by 2 for imprecision.
Effect could range from very large reduction to very large increase in outcome. Low event number. Downgrade by 2 for imprecision.
Low event number, wide CI. Downgrade by 1 for imprecision.