Trial Outcomes & Findings for Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants (NCT NCT02696343)

difference due to newborn outbound transfers to a different hospital

RT PCR gene expression profiles for CDH13 (Cadherin 13, a protein Coding gene), FOXP2 (encodes a member of the forkhead/winged-helix (FOX) family of transcription factors), NPHP4 (Nephronophthisis 4), NPY2R (Neuropeptide Y2 receptor), PLXNA1 (involved in several processes, including generation of neurons; regulation of GTPase activity; and regulation of cell shape), and Wingless-type integration site family (WNT3). Data presented here represent the median values and interquartile range, combined across measurement timepoints. All genes were run on the RT-qPCR platform in duplicate. Normalized gene expression was calculated by the delta CT-method.

NNS Bursts/min was calculated from a 2-minute digitized suck compression record sampled at 3-day intervals/week beginning a 30 weeks PMA. NNS Bursts/min represent the means and standard errors estimated by linear mixed modeling of all data samples collected for study infants over this time period.

Daily records of feeding modes (tube feed vs oral feed) and proportion of nutrient taken orally (%PO) were used to model the growth to independent Full Oral Feeds. The means and standard errors for %PO were estimated by linear mixed modeling of all data samples collected for study infants over this time period.

Automatic algorithm (NeoNNS.exe) applied to perform non-nutritive suck compression dynamics waveform discrimination to calculate the number of NNS Cycles/min. NNS Cycles/min was calculated from a 2-minute digitized suck compression waveform record sampled at 3-day intervals/week beginning a 30 weeks PMA. NNS Bursts/min represent the means and standard errors estimated by linear mixed modeling of all data samples collected for study infants over this time period.

Automated waveform discrimination (NeoNNS.exe) was used to calculate Non-nutritive Suck SpatioTemporal Index (NNS STI) based on the first 5 suck compression cycles for 5 NNS bursts. The NNS STI was calculated from a 2-minute digitized suck compression waveform record sampled at 3-day intervals/week beginning a 30-weeks PMA. The NNS STI represents the means and standard errors estimated by linear mixed modeling of all data samples collected for study infants over this time period. The range of NNS Spatiotemporal index scores falls between 100 and 20. Higher NNS STI scores mean a worse outcome, whereas lower NNS STI scores mean a better outcome.

Automatic algorithm (NeoNNS.exe) applied to perform non-nutritive suck compression dynamics waveform discrimination to calculate the NNS compression amplitude (cmH2O). This dependent measure was calculated from a 2-minute digitized suck compression waveform record sampled at 3-day intervals/week beginning at 30-weeks PMA. Non-nutritive suck compression amplitude represents the means and standard errors estimated by linear mixed modeling of all data samples collected for study infants over this time period.

Physical Growth and Feeding progression, and the mode of feeding following NICU discharge up to 18 months. The response rate for the NICHD Neonatal Research Network feed-growth questionnaire was 73/121 (60.33%). This low response rate corresponds to the height of the COVID-19 pandemic. Bivariate tests were performed to compare SHAM and NTrainer groups -- independent-samples t-test for continuous variables and chi-square test for categorical variables.

The Bayley III neurodevelopmental Cognition subtest scoring scale is used to assess cognitive development in infants and toddlers. The scoring is based on norm-referenced values. A mean score of 100 represents average function. Scores below 85 suggest mild impairment, and scores below 70 indicate moderate-to-severe impairment. Percentile scores range from 0-100.

Bayley III neurodevelopmental Language subtest is part of the Bayley Scales of Infant and Toddler Development, designed to assess language skills in young children. The scoring scale is based on norm-referenced values with a mean of 100 and a standard deviation of 15. A score below 85 suggests mild impairment, indicating that the child is "at risk" for developmental delay, while scores below 70 indicate significant developmental delay. The Bayley-III assesses language through subtests that evaluate receptive and expressive language skills, providing a comprehensive evaluation of a child's language development. Percentile scores range from 0-100.

Bayley III neurodevelopmental Motor subtest is a norm-referenced scoring scale which is used to evaluate motor skills in infants and toddlers. The motor scale includes both fine and gross motor subtests, designed to assess skills such as prehension, motor planning, and coordination. A score of 100 represents average function. A score below 85 suggests mild impairment, indicating that the child is "at risk" for developmental delay. Scores below 70 indicate significant developmental delay. Percentile scores range from 0-100.