TABLE 9.
Key Outcomes for Comparison 4: DCC Versus ICM
| Outcomes | No. Participants (Studies) | Certainty of the Evidence (GRADE) | Relative Effect (95% CI) | Risk Difference/MD (95% CI) | I2, % |
|---|---|---|---|---|---|
| Neonatal outcomes | |||||
| Survival to discharge from hospital | 1000 (5 RCTs) | ⊕⊕⊕⊝ Moderatea,b | RR: 0.99 (0.95 to 1.02) | −0.01 (−0.04 to 0.02) | 14 |
| Severe IVH: ultrasound diagnosis grades III, IV | 761 (4 RCTs) | ⊕⊕⊕⊝ Moderatec,d | RR: 0.60 (0.32 to 1.12) | −0.03 (−0.06 to 0.00) | 23 |
| CLD: oxygen at 36 wk PMA | 734 (4 RCTs) | ⊕⊕⊕⊝ Moderatea,d | RR: 0.91 (0.67 to 1.25) | −0.02 (−0.07 to 0.04) | 0 |
| NEC (Bell’s stage ≥II or any grade47; requiring surgery) | 922 (5 RCTs) | ⊕⊕⊕⊝ Moderatea,d | RR: 1.57 (0.83 to 2.97) | 0.02 (−0.01 to 0.04) | 0 |
| Peak Hb concentrations within the first 24 h after birth | 941 (6 RCTs) | ⊕⊕⊕⊝ Moderatea,e | Continuous outcome | MD: −0.02 (−0.56 to 0.53) | 52 |
| Peak Hct within the first 24 h after birth | 841 (5 RCTs) | ⊕⊕⊕⊝ Moderatea,f | Continuous outcome | MD: −0.18 (−1.90 to 1.54) | 51 |
| 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) | 236 (2 RCTs) | ⊕⊕⊕⊝ Moderatea,g | RR: 1.02 (0.92 to 1.13) | 0.06 (−0.10 to 0.22) | 43 |
| Infant outcomes | |||||
| Moderate to severe neurodevelopmental impairment in early childhood | 135 (1 RCT) | ⊕⊕⊝⊝ Lowh,i,j | RR: 0.22 (0.01 to 4.40) | −0.03 (−0.08 to 0.02) | Not estimable |
| Cerebral palsy in early childhood | 193 (2 RCTs) | ⊕⊕⊝⊝ Lowh,k | RR: 0.36 (0.01 to 8.65) | −0.01 (−0.04 to 0.02) | Not estimable |
| Significant mental developmental delay in early childhood | 39 (1 RCT) | ⊕⊝⊝⊝ Very lowh,l,m | RR: 14.06 (0.83 to 237.84) | 0.29 (0.07 to 0.52) | Not estimable |
| Legal blindness in early childhood (<20/200 visual acuity) | 58 (1 study) | — | Continuous outcome | 0.00 (−0.07 to 0.07) | 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.
Risk of bias no downgrade, although there were some concerns due to lack of blinding in most studies, because this outcome unlikely to be influenced by lack of blinding. This is a borderline decision.
Effect ranges from clinically important increase to clinically important decrease. Downgrade by 1 for imprecision.
Risk of bias no downgrade, although there were some concerns because of lack of intervention delivery blinding in most studies, because this outcome unlikely to be influenced by lack of blinding of intervention delivery. Outcome assessment blinded in all but 1 small study. This is a borderline decision.
Wide CI, relatively low event rate. Downgrade by 1 for imprecision.
Moderate heterogeneity (I2 = 52%). Downgrade by 1 for inconsistency.
Moderate heterogeneity (I2 = 51%). Downgrade by 1 for inconsistency.
Moderate heterogeneity (I2 = 43%). Downgrade by 1 for inconsistency.
Risk of bias no downgrade, although there were some concerns due to lack of blinding in most studies, because this outcome is unlikely to be influenced by lack of blinding. This is a borderline decision.
Unable to assess inconsistency (only 1 study). No downgrade.
Very wide CI, only 2 events. Downgrade by 2 for inconsistency.
Very wide CI, only 1 event. Downgrade by 2 for inconsistency.
Only 1 single-center study, this impairs generalizability. Downgrade by 1 for indirectness.
Very wide CI, very low event rate. Downgrade by 2 for imprecision.