scholarly journals A multicountry randomized controlled trial of comprehensive maternal nutrition supplementation initiated before conception: the Women First trial

2019 ◽  
Vol 109 (2) ◽  
pp. 457-469 ◽  
Author(s):  
K Michael Hambidge ◽  
Jamie E Westcott ◽  
Ana Garcés ◽  
Lester Figueroa ◽  
Shivaprasad S Goudar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Gestational Age ◽  
Maternal Nutrition ◽  
Controlled Trial ◽  
First Trimester ◽  
Maternal Body Mass Index ◽  
Low Resource ◽  
Randomized Controlled ◽  
Nutrition Supplementation ◽  
Republic Of The Congo

ABSTRACT Background Reported benefits of maternal nutrition supplements commenced during pregnancy in low-resource populations have typically been quite limited. Objectives This study tested the effects on newborn size, especially length, of commencing nutrition supplements for women in low-resource populations ≥3 mo before conception (Arm 1), compared with the same supplement commenced late in the first trimester of pregnancy (Arm 2) or not at all (control Arm 3). Methods Women First was a 3-arm individualized randomized controlled trial (RCT). The intervention was a lipid-based micronutrient supplement; a protein-energy supplement was also provided if maternal body mass index (kg/m2) was <20 or gestational weight gain was less than recommendations. Study sites were in rural locations of the Democratic Republic of the Congo (DRC), Guatemala, India, and Pakistan. The primary outcome was length-for-age z score (LAZ), with all anthropometry obtained <48 h post delivery. Because gestational ages were unavailable in DRC, outcomes were determined for all 4 sites from WHO newborn standards (non-gestational-age-adjusted, NGAA) as well as INTERGROWTH-21st fetal standards (3 sites, gestational age-adjusted, GAA). Results A total of 7387 nonpregnant women were randomly assigned, yielding 2451 births with NGAA primary outcomes and 1465 with GAA outcomes. Mean LAZ and other outcomes did not differ between Arm 1 and Arm 2 using either NGAA or GAA. Mean LAZ (NGAA) for Arm 1 was greater than for Arm 3 (effect size: +0.19; 95% CI: 0.08, 0.30, P = 0.0008). For GAA outcomes, rates of stunting and small-for-gestational-age were lower in Arm 1 than in Arm 3 (RR: 0.69; 95% CI: 0.49, 0.98, P = 0.0361 and RR: 0.78; 95% CI: 0.70, 0.88, P < 0.001, respectively). Rates of preterm birth did not differ among arms. Conclusions In low-resource populations, benefits on fetal growth–related birth outcomes were derived from nutrition supplements commenced before conception or late in the first trimester. This trial was registered at clinicaltrials.gov as NCT01883193.

scholarly journals Fish Oil Supplementation in Pregnancy Increases Gestational Age, Size for Gestational Age, and Birth Weight in Infants: A Randomized Controlled Trial

2018 ◽  
Vol 149 (4) ◽  
pp. 628-634 ◽  
Author(s):  
Rebecca Kofod Vinding ◽  
Jakob Stokholm ◽  
Astrid Sevelsted ◽  
Bo L Chawes ◽  
Klaus Bønnelykke ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Birth Weight ◽  
Pregnant Women ◽  
Gestational Age ◽  
Controlled Trial ◽  
Growth Curves ◽  
Vitamin D Supplementation ◽  
Double Blind ◽  
Randomized Controlled ◽  
In Pregnancy

ABSTRACT Background Randomized trials have reported that supplementation with n–3 long-chain polyunsaturated fatty acids (LCPUFAs) in pregnancy can prolong pregnancy and thereby increase birth weight. Objective We aimed to examine the relations of n–3 LCPUFA supplementation in pregnancy with duration of pregnancy, birth weight, and size for gestational age (GA). Methods This was a double-blind randomized controlled trial conducted in 736 pregnant women and their offspring, from the Copenhagen Prospective Studies on Asthma in Childhood2010cohort. They were recruited between weeks 22 and 26 in pregnancy and randomly assigned to either of 2.4 g n–3 LCPUFA or control (olive oil) daily until 1 wk after birth. Exclusion criteria were endocrine, cardiovascular, or nephrologic disorders and vitamin D supplementation intake >600 IU/d. In this study we analyzed secondary outcomes, and further excluded twin pregnancies and extrauterine death. The primary outcome for the trial was persistent wheeze or asthma. Results The random assignment ran between 2008 and 2010. Six hundred and ninety-nine mother-infant pairs were included in the analysis. n–3 LCPUFA compared with control was associated with a 2-d prolongation of pregnancy [median (IQR): 282 (275–288) d compared with 280 (273–286) d, P = 0.02], a 97-g higher birth weight (mean ± SD: 3601 ± 534 g compared with 3504 ± 528 g, P = 0.02), and an increased size for GA according to the Norwegian population-based growth curves-Skjærven (mean ± SD: 49.9 ± 28.3 percentiles compared with 44.5 ± 27.6 percentiles, P = 0.01). Conclusion Supplementing pregnant women with n–3 LCPUFAs during the third trimester is associated with prolonged gestation and increased size for GA, leading to a higher birth weight in this randomized controlled trial. This trial was registered at clinicaltrials.gov as NCT00798226.

scholarly journals Family-Centered Care Enhanced Neonatal Neurophysiological Function in Preterm Infants: Randomized Controlled Trial

2019 ◽  
Vol 99 (12) ◽  
pp. 1690-1702 ◽  
Author(s):  
Yen-Ting Yu ◽  
Wan-Chi Huang ◽  
Wu-Shiun Hsieh ◽  
Jui-Hsing Chang ◽  
Chyi-Her Lin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Birth Weight ◽  
Preterm Infants ◽  
Gestational Age ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Oddball Task ◽  
Appropriate For Gestational Age ◽  
Related Potentials ◽  
Family Centered

Abstract Background Family-centered intervention for preterm infants has shown short- to medium-term developmental benefits; however, the neurological effects of intervention have rarely been explored. Objective The objectives of this study were to examine the effect of a family-centered intervention program (FCIP) on neurophysiological functions in preterm infants with very low birth weight (VLBW; birth weight of &lt; 1500 g) in Taiwan, to compare the effect of the FCIP with that of a usual-care program (UCP), and to explore the FCIP-induced changes in neurobehavioral and neurophysiological functions. Design This was a multicenter, single-blind randomized controlled trial. Setting The study took place in 3 medical centers in northern and southern Taiwan. Participants Two hundred fifty-one preterm infants with VLBW were included. Intervention The FCIP group received a family-centered intervention and the UCP group received standard care during hospitalization. Measurements Infants were assessed in terms of neurobehavioral performance using the Neonatal Neurobehavioral Examination–Chinese version, and their neurophysiological function was assessed using electroencephalography/event-related potentials during sleep and during an auditory oddball task during the neonatal period. Results The FCIP promoted more mature neurophysiological function than the UCP, including greater negative mean amplitudes of mismatch negativities in the left frontal region in the oddball task in all infants, lower intrahemispheric prefrontal-central coherence during sleep in infants who were small for gestational age, and higher interhemispheric frontal coherence during sleep in those who were appropriate for gestational age. Furthermore, interhemispheric coherence was positively associated with the total neurobehavioral score in preterm infants who were appropriate for gestational age (r = 0.20). Limitations The fact that more parental adherence strategies were used in the FCIP group than in the UCP group might have favored the intervention effect in this study. Conclusions Family-centered intervention facilitates short-term neurophysiological maturation in preterm infants with VLBW in Taiwan.

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