The CLIMB (Complex Lipids In Mothers and Babies) study: protocol for a multicentre, three-group, parallel randomised controlled trial to investigate the effect of supplementation of complex lipids in pregnancy, on maternal ganglioside status and subsequent cognitive outcomes in the offspring

Abstract

IntroductionComplex lipids are important constituents of the central nervous system. Studies have shown that supplementation with complex milk lipids (CML) in pregnancy may increase the level of fetal gangliosides (GA), with the potential to improve cognitive outcomes.Methods and analysisWe aim to recruit approximately 1500 pregnant women in the first trimester (11–14 weeks) and randomise them into one of the three treatment groups: standard maternal milk formulation, CML-enhanced maternal milk formulation or no maternal milk intervention with standard pregnancy advice (ie, the standard care). Maternal lifestyle and demographic data will be collected throughout the pregnancy, as well as biological samples (eg, blood, hair, urine, buccal smear, cord blood, cord and placenta samples). Data from standard obstetric care recorded in hospital maternity notes (eg, ultrasound reports, results of oral glucose tolerance test and pregnancy outcome data) will also be extracted. Postnatal follow-up will be at 6 weeks and 12 months of age, at which point infant cognitive development will be assessed (Bayley Scales of Infant Development I).Ethics and disseminationThis project was approved by the Ethics Committee of Chongqing Medical University. Dissemination of findings will take the form of publications in peer-reviewed journals and presentations at national and international conferences.Trial registration numberChiCTR-IOR-16007700; Pre-results.

Associations of air pollution exposures in preconception and pregnancy with birth outcomes and infant neurocognitive development: analysis of the Complex Lipids in Mothers and Babies (CLIMB) prospective cohort in Chongqing, China

“…Participant recruitment in the CLIMB cohort has been described previously. 18 In brief, women who were between 20 and 40 years of age and were at 11–14 weeks gestation with a singleton pregnancy were eligible for participation. Women were excluded if they had a self-stated history of premature delivery before 32 weeks of gestation, maternal milk allergy or aversion or severe lactose intolerance.…”

“…The current study leveraged the Complex Lipids in Mothers and Babies (CLIMB) cohort, a prospective birth cohort recruited in Chongqing, China, 18 with trimester-specific maternal PM 2.5 and NO 2 air pollution exposure derived from a spatio-temporal land use regression (LUR) model. 19 The aim of this analysis was to examine the associations between PM 2.5 and NO 2 exposures during pre-pregnancy and during pregnancy, with birth and infant neurocognitive development outcomes at 12 months of age.…”