Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation.

BACKGROUND: We tested the hypothesis that routine MRI would improve the care and well-being of preterm infants and their families. DESIGN: Parallel-group randomised trial (1.1 allocation; intention-to-treat) with nested diagnostic and cost evaluations (EudraCT 2009-011602-42). SETTING: Participants from 14 London hospitals, imaged at a single centre. PATIENTS: 511 infants born before 33 weeks gestation underwent both MRI and ultrasound around term. 255 were randomly allocated (siblings together) to receive only MRI results and 255 only ultrasound from a paediatrician unaware of unallocated results; one withdrew before allocation. MAIN OUTCOME MEASURES: Maternal anxiety, measured by the State-Trait Anxiety inventory (STAI) assessed in 206/214 mothers receiving MRI and 217/220 receiving ultrasound. Secondary outcomes included: prediction of neurodevelopment, health-related costs and quality of life. RESULTS: After MRI, STAI fell from 36.81 (95% CI 35.18 to 38.44) to 32.77 (95% CI 31.54 to 34.01), 31.87 (95% CI 30.63 to 33.12) and 31.82 (95% CI 30.65 to 33.00) at 14 days, 12 and 20 months, respectively. STAI fell less after ultrasound: from 37.59 (95% CI 36.00 to 39.18) to 33.97 (95% CI 32.78 to 35.17), 33.43 (95% CI 32.22 to 34.63) and 33.63 (95% CI 32.49 to 34.77), p=0.02. There were no differences in health-related quality of life. MRI predicted moderate or severe functional motor impairment at 20 months slightly better than ultrasound (area under the receiver operator characteristic curve (CI) 0.74; 0.66 to 0.83 vs 0.64; 0.56 to 0.72, p=0.01) but cost £315 (CI £295-£336) more per infant. CONCLUSIONS: MRI increased costs and provided only modest benefits. TRIAL REGISTRATION: ClinicalTrials.gov NCT01049594 https://clinicaltrials.gov/ct2/show/NCT01049594. EudraCT: EudraCT: 2009-011602-42 (https://www.clinicaltrialsregister.eu/).

Association between limiting longstanding illness in mothers and their children: findings from the UK Millennium Cohort Study.

OBJECTIVE: To explore the association between maternal disability as measured by the presence of a limiting longstanding illness (LLI) 9 months postpartum and subsequent child health at the age of 7 years. DESIGN: Nationally representative prospective longitudinal study. SETTING: England, Scotland, Wales and Northern Ireland. PARTICIPANTS: Secondary analysis of data on 11 807 mother-child pairs recruited to the UK Millennium Cohort Study. Baseline interviews with mothers were carried out in 2001-2002. When the children were 7 years old, the follow-up survey included questions about limiting longstanding health conditions in the child. PRIMARY OUTCOME MEASURE: Any longstanding condition that was reported to limit the children's activities in any way. RESULTS: Nearly 7% of all children were reported to have an LLI at the age of 7 years. The majority (88.1%, 95% CI 85.6% to 90.2%) of children whose mother was disabled did not have an LLI themselves. The children of disabled mothers, however, had higher odds of LLI (OR=1.9, 95% CI 1.5 to 2.5) independently of different maternal, pregnancy and birth characteristics and breast feeding duration. Inclusion of poverty measures in the model did not significantly affect the odds (OR=1.8, 95% CI 1.4 to 2.4), suggesting that maternal LLI around the time of birth increases the odds of child LLI at the age of 7 years independently of starting life in poverty. CONCLUSIONS: There is a strong positive association between maternal and child LLI. Health professionals should work together with social care and other relevant service providers to identify the individual needs of disabled parents and provide adequate support throughout the pregnancy and after the child is born. Further research is important to clarify the exact nature of the associations for different types of maternal and child disability.

Parents' experiences of information and communication in the neonatal unit about brain imaging and neurological prognosis: a qualitative study.

AIM: To explore parental information and communication needs during their baby's care in the neonatal unit with a focus on brain imaging and neurological prognosis. METHODS: Eighteen parents recruited from one neonatal unit in the United Kingdom participated in semi-structured qualitative interviews using a grounded theory approach. The topic guide focused on information received about neonatal brain imaging, diagnosis and prognosis, emotional impact and support. RESULTS: Parents expressed different information needs influenced by their history, expectations, coping strategies and experiences. Most felt they initially were passive recipients of information and attempted to gain control of the information flow. Nurses were the main providers of information; doctors and other parents were also valuable. Attending ward rounds was important. Some parents felt accessing specific information such as the results of brain imaging could be difficult. Concerns about long-term developmental outcomes and the need for information did not diminish over time. The emotional impact of having a preterm baby had a negative effect on parents' ability to retain information, and all had an ongoing need for reassurance. CONCLUSION: The findings provide insights about the needs and experiences of parents who have a continuing requirement for information about their infant's care, development and prognosis.

A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years.

OBJECTIVE: The authors performed a randomised trial in very preterm small-for-gestational age (SGA) babies to determine if prophylaxis with granulocyte-macrophage colony-stimulating factor (GM-CSF) improves outcomes (the PROGRAMS trial). Despite increased neutrophil counts following GM-CSF, the authors reported no significant difference in neonatal sepsis-free survival. PATIENTS AND METHODS: 280 babies born <31 weeks of gestation and SGA were entered into the trial. Outcome was determined at 2 years to determine neurodevelopmental and general health outcomes, including economic costs. RESULTS: The authors found no significant differences in health outcomes or health and social care costs between the trial groups. In the GM-CSF arm, 87 of 134 (65%) babies survived to 2 years without severe disability compared with 87 of 131 (66%) controls (RR: 1·0, 95% CI 0·8 to 1·2). Marginally, more children receiving GM-CSF were reported to have cough (RR 1·7, 95% CI 1·1 to 2·6) and had signs of chronic respiratory disease (Harrison's sulcus; RR 2·0, 95% CI 1·0 to 3·9) though this was not reflected in bronchodilator use or need for hospitalisation for respiratory disease. Overall, the rate of neurologic abnormality (7%-9%) was similar but mean overall developmental scores were lower than expected for gestational age. CONCLUSIONS: The administration of GM-CSF to very preterm SGA babies is not associated with improved or more adverse outcomes at 2 years of age. The apparent excess of developmental impairment in the entire PROGRAMS cohort, without corresponding increase in neurological abnormality, may represent diffuse brain injury attributable to intrauterine growth restriction.

Prevalence and impact of disability in women who had recently given birth in the UK.

BACKGROUND: Maternity services should take into account the needs of all women, including those related to disability. No reliable information, however, exists on the extent and characteristics of disability in this population in the UK. This brief report provides an overview of the prevalence of disability in women giving birth in the UK as measured by the presence of a limiting longstanding illness (LLI). The demographic, socio-economic, lifestyle and pregnancy related characteristics and child health outcomes are summarised to inform maternity and postnatal care service planning, and policy development. METHODS: Secondary analysis of data on 18,231 mother-child pairs from the nationally representative UK Millennium Cohort Study. The baseline interviews with families were carried out in 2001-2002. The LLI prevalence in women who had recently delivered was estimated, and relevant characteristics and differences in outcomes compared using descriptive statistics taking into account the study design and non-response. RESULTS: 9.4% (95% CI 8.7-10.0) of women who had recently given birth reported having an LLI. Musculoskeletal, respiratory and mental disorders accounted for most of the health problems. A significantly higher proportion of women with an LLI received means-tested financial benefits, had no educational qualifications and suffered from intimate partner violence compared to women who did not have an LLI (49.3% vs 35.3%, 20.4% vs 15.0%, 6.0% vs 3.3%, respectively). They were also more likely to smoke throughout pregnancy than women without an LLI (29.2% vs 20.8%), have a preterm birth (10.9% vs 6.8%) and be lone parents (19.5% vs 13.9%). Only 25.6% of children of mothers with an LLI were breastfed for more than three months compared to 33.4% of infants of mothers who did not have an LLI. At the age of seven years, 12.0% of children of mothers with an LLI had an activity limiting health problem themselves compared to 6.2% of children of mothers without an LLI. CONCLUSIONS: Disability in women who had recently delivered is relatively common. It is associated with social and economic inequalities and worse pregnancy and child related outcomes. Apart from condition-specific support during and after pregnancy, disabled women may require extra help from health professionals to quit smoking, continue breastfeeding, and reduce intimate partner violence.