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Effects of Early Intervention on Visual Function in Preterm Infants: A Randomized Controlled Trial.

ABSTRACT: Objectives: To determine the effectiveness of an early intervention program in enhancing visual function in very preterm infants. Methods: We conducted a RCT. We included preterm infants born between 25+0 and 29+6 weeks of gestational age (GA), without severe morbidities, and their families. Infants were randomized to either receive Standard Care (SC) or Early Intervention (EI). SC, according to NICU protocols, included Kangaroo Mother Care and minimal handling. EI included, in addition to routine care, parental training according to the PremieStart program, and multisensory stimulation (infant massage and visual interaction) performed by parents. Visual function was assessed at term equivalent age (TEA) using a prevalidated battery evaluating ocular spontaneous motility, ability to fix and follow a target, reaction to color, stripes discrimination and visual attention at distance. Results: Seventy preterm (EI n = 34, SC n = 36) infants were enrolled. Thirteen were excluded according to protocol. Fifty-seven infants (EI = 27, SC = 30) were assessed at TEA. The two groups were comparable for parental and infant characteristics. In total, 59% of infants in the EI group achieved the highest score in all the nine assessed items compared to 17% in the SC group (p = 0.001): all infants in both groups showed complete maturation in four items, but EI infants showed more mature findings in the other five items (ocular motility both spontaneous and with target, tracking arc, stripes discrimination and attention at distance). Conclusions: Our results suggest that EI has a positive effect on visual function maturation in preterm infants at TEA. Trial Registration: clinicalTrial.gov (NCT02983513).

SUBMITTER: Fontana C

PROVIDER: S-EPMC7287146 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Effects of Early Intervention on Visual Function in Preterm Infants: A Randomized Controlled Trial.

Fontana Camilla C De Carli Agnese A Ricci Daniela D Dessimone Francesca F Passera Sofia S Pesenti Nicola N Bonzini Matteo M Bassi Laura L Squarcina Letizia L Cinnante Claudia C Mosca Fabio F Fumagalli Monica M

Frontiers in pediatrics 20200604

Objectives: To determine the effectiveness of an early intervention program in enhancing visual function in very preterm infants. Methods: We conducted a RCT. We included preterm infants born between 25+0 and 29+6 weeks of gestational age (GA), without severe morbidities, and their families. Infants were randomized to either receive Standard Care (SC) or Early Intervention (EI). SC, according to NICU protocols, included Kangaroo Mother Care and minimal handling. EI i ...[more]

PMID: 32582595

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Project description:BackgroudThe aim of the study was to evaluate the effect of early parenteral iron supplementation combined erythropoietin for prevention of anemia in preterm infants.MethodsIn total, 96 preterm infants were randomly assigned to 3 groups: a control group receiving standard parenteral nutrition (group 1: n = 31), an iron-supplemented group (group 2: IS, n = 33), and an iron-supplemented combined erythropoietin group (group 3: IS+EPO, n = 32). The primary objective was to assess hemoglobin (Hb) levels. The secondary objectives included assessment of red blood cell counts (RBC), mean cell volume (MCV), serum iron, ferritin, percentages of reticulocyte (RET), total iron binding capacity (TIBC) and oxidative stress, which was assessed by measuring plasma levels of malondialdehyde and superoxide dismutase at baseline and at 2 weeks. The blood routine indices including Hb, RBC, MCV, and percentages of RET were measured at corrected age of 1 and 3 months.ResultsAt 2 weeks of life, the percentages of reticulocyte in group 2 and group 3 were significantly higher than those in group 1 (2.1±0.4, 2.5±0.3, and 1.7±0.3, respectively, P < 0.001, P<0.001), whereas TIBC were significantly lower than those in group 1 (36.7±4.6, 36.0±4.7, and 41.6 ± 5.2 respectively, P = 0.011, P = 0.006). There were no significant differences in RBC counts, the levels of hemoglobin, ferritin, malondialdehyde, and superoxide dismutase among the 3 groups at 2weeks of life. RBC, Hb, MCV, body weight, body length, and head circumference at a corrected age of 1 month did not differ among 3 groups. At corrected age of 3months, more infants in the control group had abnormal Hb and MCV levels (Hb levels: 114.3 ± 21.3, 123.7 ± 31.6, and 125.1 ± 21.2, P = 0.021, P = 0.034, respectively; MCV: 74.1 ± 3.5, 78.3 ± 4.7 and 79.1 ± 5.2, P = 0.017, P = 0.012, respectively), whereas cases of oral iron, cases of breastfeeding, RBC, body weight, body length, and head circumference were not different among 3 groups.ConclusionEarly parenteral iron supplementation combined erythropoietin in preterm infants improved the percentages of reticulocyte, decreased total iron binding capacity, and improved the Hb and MCV levels at 3 months of age. Early parenteral iron supplementations with EPO were beneficial for the preterm infants.

Project description:BackgroundThe implementation of early intervention (EI) in medical settings is time-consuming and resource-intensive, which limits its extensive use. In 2018, the Chinese Eugenics Association developed a home-based, post-discharge EI program. This study aims at evaluating the impact of this EI program on neurodevelopment and physical growth of early preterm infants.MethodsThis study was a prospective, partially blinded, randomized controlled trial (RCT), followed by an open phase. A total of 73 infants born at 28+ 0 ~ 31+ 6 weeks' gestation who were admitted to the Children's Hospital of Chongqing Medical University between December 1, 2019, and June 31, 2020, were enrolled. Another 33 infants were retrospectively recruited as the reference group. Thirty-seven infants randomized in the first early intervention, then standard care (EI-SC) group performed a 30-day EI during RCT period, while 36 infants allocated to SC-EI group were given EI in the following open phase. The test of infant motor performance (TIMP), development quotient (DQ), and anthropometric measures (length, weight, head circumference) were measured at the baseline (T0), termination of the RCT (T1), and termination of the open phase (T2). Repeated measures analysis was performed for comparison among groups.ResultsFrom T0 to T1, both groups had significant improvements in all outcome measures (all p < 0.001). A 30-day EI program was more effective in improving TIMP than standard care (from 53.12 ± 8.79 to 83.50 ± 11.85 in EI-SC group vs from 50.52 ± 8.64 to 75.97 ± 13.44 in SC-EI group, F = 4.232, p = 0.044). EI-SC group also had greater improvements in length, weight, and head circumference than SC-EI group (all p < 0.05). From T0 to T2, there was no significant difference regarding the improvements in all outcomes between the groups (all p > 0.05). At the endpoint of T2, the EI-SC and SC-EI group had similar TIMP and anthropometric measures, but much higher than the reference group (all p < 0.05).ConclusionsThese findings demonstrated that a home-based, post-discharge EI program in this study was a practical approach to promote motor development and physical growth in early preterm infants.Trial registrationCHICTR, CTR1900028330, registered December 19, 2019, https:// http://www.chictr.org.cn/showproj.aspx?proj=45706.

Project description:BackgroundDue to insufficient evidence, extremely preterm infants (≤28 wk of gestation) rarely receive early progressive feeding (small increments of feeding volumes between 1 and 4 d after birth). We hypothesized that early progressive feeding increases the number of full enteral feeding days in the first month after birth.ObjectiveThe aim of this study was to determine the feasibility and efficacy of early progressive feeding in extremely preterm infants.DesignIn this single-center randomized trial, extremely preterm infants born between September 2016 and June 2017 were randomly assigned to receive either early progressive feeding without trophic feeding (early feeding group) or delayed progressive feeding after a 4-d course of trophic feeding (delayed feeding group). Treatment allocation occurred before or on feeding day 1. The primary outcome was the number of full enteral feeding days in the first month after birth. Secondary outcomes were death, necrotizing enterocolitis (NEC), culture-proven sepsis, growth percentiles at 36 wk postmenstrual age, use of parenteral nutrition, and need for central venous access.ResultsSixty infants were included (median gestational age: 26 wk; mean ± SD birth weight: 832 ± 253 g). The primary outcome differed between groups (median difference favoring the early feeding group: +2 d; 95% CI: 0, 3 d; P = 0.02). Early progressive feeding reduced the use of parenteral nutrition (4 compared with 8 d; P ≤ 0.01) and the need for central venous access (9 compared with 13 d; P ≤ 0.01). The outcome of culture-proven sepsis (10% compared with 27%; P = 0.18), restricted growth (weight, length, and head circumference <10th percentile) at 36 wk postmenstrual age (25% compared with 50%; P = 0.07), and the composite outcome of NEC or death (27% compared with 20%; P = 0.74) did not differ between groups.ConclusionEarly progressive feeding increases the number of full enteral feeding days in extremely preterm infants. This trial was registered at www.clinicaltrials.gov as NCT02915549.

Dataset Information

Effects of Early Intervention on Visual Function in Preterm Infants: A Randomized Controlled Trial.

Publications

Effects of Early Intervention on Visual Function in Preterm Infants: A Randomized Controlled Trial.

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