Midtrimester preterm prelabour rupture of membranes (PPROM):expectant management or amnioinfusion for improving perinatal outcomes (PPROMEXIL - III trial)

BACKGROUND: Babies born after midtrimester preterm prelabour rupture of membranes (PPROM) are at risk to develop neonatal pulmonary hypoplasia. Perinatal mortality and morbidity after this complication is high. Oligohydramnios in the midtrimester following PPROM is considered to cause a delay in lung development. Repeated transabdominal amnioinfusion with the objective to alleviate oligohydramnios might prevent this complication and might improve neonatal outcome. METHODS/DESIGN: Women with PPROM and persisting oligohydramnios between 16 and 24 weeks gestational age will be asked to participate in a multi-centre randomised controlled trial. Intervention: random allocation to (repeated) abdominal amnioinfusion (intervention) or expectant management (control). The primary outcome is perinatal mortality. Secondary outcomes are lethal pulmonary hypoplasia, non-lethal pulmonary hypoplasia, survival till discharge from NICU, neonatal mortality, chronic lung disease (CLD), number of days ventilatory support, necrotizing enterocolitis (NEC), periventricular leucomalacia (PVL) more than grade I, severe intraventricular hemorrhage (IVH) more than grade II, proven neonatal sepsis, gestational age at delivery, time to delivery, indication for delivery, successful amnioinfusion, placental abruption, cord prolapse, chorioamnionitis, fetal trauma due to puncture. The study will be evaluated according to intention to treat. To show a decrease in perinatal mortality from 70% to 35%, we need to randomise two groups of 28 women (two sided test, β-error 0.2 and α-error 0.05). DISCUSSION: This study will answer the question if (repeated) abdominal amnioinfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities. Moreover, it will assess the risks associated with this procedure. TRIAL REGISTRATION: NTR3492 Dutch Trial Register (http://www.trialregister.nl)

Pentalogy of Cantrell: two patients and a review to determine prognostic factors for optimal approach

Two patients with incomplete pentalogy of Cantrell are described. The first was a girl with a large omphalocele with evisceration of the heart, liver and intestines with an intact sternum. Echocardiography showed profound intracardiac defects. The girl died 33 h after birth. The second patient was a female fetus with ectopia cordis (EC) without intracardiac anomalies; a large omphalocele with evisceration of the heart, stomach, spleen and liver; a hypoplastic sternum and rib cage; and a scoliosis. The pregnancy was terminated. A review of patients described in the literature is presented with the intention of finding prognostic factors for an optimal approach to patients with the pentalogy of Cantrell. In conclusion the prognosis seems to be poorer in patients with the complete form of pentalogy of Cantrell, EC, and patients with associated anomalies. Intracardial defects do not seem to be a prognostic factor

The bilirubin albumin ratio in the management of hyperbilirubinemia in preterm infants to improve neurodevelopmental outcome: A randomized controlled trial - BARTrial

Background and Objective: High bilirubin/albumin (B/A) ratios increase the risk of bilirubin neurotoxicity. The B/A ratio may be a valuable measure, in addition to the total serum bilirubin (TSB), in the management of hyperbilirubinemia. We aimed to assess whether the additional use of B/A ratios in the management of hyperbilirubinemia in preterm infants improved neurodevelopmental outcome. Methods: In a prospective, randomized controlled trial, 615 preterm infants of 32 weeks' gestation or less were randomly assigned to treatment based on either B/A ratio and TSB thresholds (consensus-based), whichever threshold was crossed first, or on the TSB thresholds only. The primary outcome was neurodevelopment at 18 to 24 months' corrected age as assessed with the Bayley Scales of Infant Development III by investigators unaware of treatment allocation. Secondary outcomes included complications of preterm birth and death. Results: Composite motor (100±13 vs. 101±12) and cognitive (101±12 vs. 101±11) scores did not differ between the B/A ratio and TSB groups. Demographic characteristics, maximal TSB levels, B/A ratios, and other secondary outcomes were similar. The rates of death and/or severe neurodevelopmental impairment for th

The ages and stages questionnaire and neurodevelopmental impairment in two-year-old preterm-born children

Objective: To test the ability of the Ages and Stages Questionnaire, Third Edition (ASQ3) to help identify or exclude neurodevelopmental impairment (NDI) in very preterm-born children at the corrected age of two. Methods: We studied the test results of 224 children, born a

Flowchart with numbers of eligible and included children.

<p>ASQ3; Ages and Stages Questionnaire, Third Edition, time window 22–26 months corrected age. BSIDIII: Bayley Scales of Infant and Toddler Development, Third Edition, time window 21–30 months corrected age. NDI: Neurodevelopmental Impairment: BSIDIII cognitive score or composite motor score <70, bilateral blindness/deafness or cerebral palsy.</p

Characteristics of the study sample.

<p>Data are expressed as mean ± SD and [range], or median and (25–75 percentile)</p><p>ASQ3: Ages and Stages Questionnaire, Third Edition</p><p>BSIDIII: Bayley Scales of Infant and Toddler Development, Third Edition</p><p>Characteristics of the study sample.</p

Correlation between BSIDIII combined cognitive and composite motor scores and ASQ3 total scores.

<p>R square is 0.417, p<0.001. Incomplete BSID scores due to CP or severe mental impairment were imputed at 50 and incomplete ASQ scores were imputed with 0 points per item without a valid score.</p

ASQ3 failures and the domains for different NDI thresholds.

<p>Data are presented as numbers and percentages.</p><p>ASQ3: Ages and Stages Questionnaire, Third edition.</p><p>Failure ASQ3: a score of >2 SD below the mean score for the U.S. reference group on any domain</p><p>BSIDIII: Bayley Scales of Infant and Toddler Development, Third Edition.</p><p>NDI with BSIDIII<70: neurodevelopmental impairment with BSIDIII cognitive score or composite motor score of <70, bilateral blindness/deafness and/or cerebral palsy.</p><p>NDI with BSIDIII<80: neurodevelopmental impairment with BSIDIII cognitive score or composite motor score of <80, bilateral blindness/deafness and/or cerebral palsy.</p><p>NDI with BSIDIII<85: neurodevelopmental impairment with BSIDIII cognitive score or composite motor score of <85, bilateral blindness/deafness and/or cerebral palsy.</p><p>ASQ3 failures and the domains for different NDI thresholds.</p

ASQ3 total scores for children with No NDI and children with NDI.

<p>NDI with BSID threshold set at < 70. Incomplete BSIDIII scores due to CP or severe mental impairment were imputed at 50 and incomplete ASQ3 scores were imputed with 0 points per item without a valid score.**** <i>p</i>< 0.0001</p

ROC curve for NDI with BSIDIII threshold< 70 versus ASQ3 total scores.

<p>Area under the curve 96% p<0.0001</p