Epigenetics and Protective Factors in the Preterm Infant (EPIC)
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ClinicalTrials.gov Identifier: NCT04804280 |
Recruitment Status :
Recruiting
First Posted : March 18, 2021
Last Update Posted : October 18, 2023
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Condition or disease | Intervention/treatment |
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Preterm Birth Parent-Child Relations Epigenetics | Genetic: DNA methylation of target genes Diagnostic Test: Functional Magnetic Resonance Imaging (fMRI) acquisition |
Study Type : | Observational |
Estimated Enrollment : | 94 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Epigenetics and Protective Factors in the Preterm Infant: Neural and Methylation Correlates of Developmental Care During Neonatal Intensive Care Unit Hospitalization |
Actual Study Start Date : | January 1, 2019 |
Estimated Primary Completion Date : | April 4, 2024 |
Estimated Study Completion Date : | September 4, 2024 |
Group/Cohort | Intervention/treatment |
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Preterm children (PT)
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Genetic: DNA methylation of target genes
The methylation status of target genes (BDNF, SLC6A4, OXTR, NR3C1) will be investigated. Cord blood will be collected at birth for PT and FT, only for PT a peripheral blood sample will be collected at hospital discharge, during routine clinical procedures. Genomic DNA will be extracted from aliquots of 0. 2 ml of each blood sample with the GeneElute Blood Genomic DNA kit (Sigma) and stored at -20°C. Aliquots of 250 ng of each DNA will be edited for methylation analysis with the EZ DNA Methylation Lightning kit (Zymo Research). Amplification of samples and their preparation for NGS sequencing will be performed. Samples will be sequenced on NextSeq 500 (Illumina). Individual processed sequences (PE reads) will be independently aligned to reference sequences using a parallel Smith-Waterman algorithm. Only reads that consistently align to the same reference sequence will be retained. At each CpG site in each analyzed sequence, the frequencies of the four bases will be evaluated. Diagnostic Test: Functional Magnetic Resonance Imaging (fMRI) acquisition Infants will undergo an MRI exam with a 3 Tesla Philips Achieva scanner and a 32-channel head coil. a trained experimenter will apply tactile stimulation associated with affective touch characteristics to the child with a soft brush on the right anterior tibial region in proximal and distal directions. The length of the stimulated area will be measured to cover approximately 15 cm, and tactile stimulations will be applied at a rate of 5 cm/s for 15s, with randomized intervals between stimuli of 10-15s (resulting in 5 stimulations in a 15s block). A regular audio signal will help the researcher to keep a constant stroke velocity. Audio commands will also be used to direct the experimenter. Infant must be asleep (natural sleep) during the fMRI acquisition. |
Full-term children (FT)
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Genetic: DNA methylation of target genes
The methylation status of target genes (BDNF, SLC6A4, OXTR, NR3C1) will be investigated. Cord blood will be collected at birth for PT and FT, only for PT a peripheral blood sample will be collected at hospital discharge, during routine clinical procedures. Genomic DNA will be extracted from aliquots of 0. 2 ml of each blood sample with the GeneElute Blood Genomic DNA kit (Sigma) and stored at -20°C. Aliquots of 250 ng of each DNA will be edited for methylation analysis with the EZ DNA Methylation Lightning kit (Zymo Research). Amplification of samples and their preparation for NGS sequencing will be performed. Samples will be sequenced on NextSeq 500 (Illumina). Individual processed sequences (PE reads) will be independently aligned to reference sequences using a parallel Smith-Waterman algorithm. Only reads that consistently align to the same reference sequence will be retained. At each CpG site in each analyzed sequence, the frequencies of the four bases will be evaluated. Diagnostic Test: Functional Magnetic Resonance Imaging (fMRI) acquisition Infants will undergo an MRI exam with a 3 Tesla Philips Achieva scanner and a 32-channel head coil. a trained experimenter will apply tactile stimulation associated with affective touch characteristics to the child with a soft brush on the right anterior tibial region in proximal and distal directions. The length of the stimulated area will be measured to cover approximately 15 cm, and tactile stimulations will be applied at a rate of 5 cm/s for 15s, with randomized intervals between stimuli of 10-15s (resulting in 5 stimulations in a 15s block). A regular audio signal will help the researcher to keep a constant stroke velocity. Audio commands will also be used to direct the experimenter. Infant must be asleep (natural sleep) during the fMRI acquisition. |
- DNA methylation changes in PT [ Time Frame: first 6 months (Corrected Age for PT) of infant's life ]Correlation between DNA methylation changes of target genes (BDNF, SLC6A4, OXTR, NR3C1) and the duration of Developmental Care practice that involved proximity and pyisical contact during the NICU stay measured by a specific APP.
- Insular cortex and somatosensory cortex activation in PT and FT infants [ Time Frame: when the infants is 2 months-old (Corrected Age for PT) ]Significant differences in mean BOLD signal magnitude in the insular cortex and in somatosensory cortex between PT and FT in the slow skin stroking experimental task during the fMRI session.
- Developmental Care procedures in NICU and insular cortex/somatosensory cortex activation in preterm infants [ Time Frame: first 2 months (Corrected Age for PT) of infant's life ]Correlation between the duration of Developmental Care practice taht involved proximity and physical contact during the NICU stay measured by a specific APP and mean BOLD signal magnitude in the insular cortex and in somatosensory cortex (in the slow skin stroking experimental task during the fMRI session) in PT.
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | up to 30 Minutes (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Preterm infants. Preterm infants infants will be pre-screened for medical status variables by the NICU neonatologists of different hospital in Lombardy. Following a letter outlining the general research, parents will be meet per person in NICU or contacted by telephone and asked to voluntarily participate.
Full-term infants. Mothers and their infants will be enrolled during the prenatal/ postnatal parenting coursein different hospital in Lombardy. Following a letter outlining the general research, parents will be contacted by telephone and asked to voluntarily participate.
Inclusion criteria for PT children are:
- gestational age: 26+0 to 31+6 weeks;
- absence of documented neurological pathology;
- absence of sensory deficits;
- absence of malformative syndromes and/or major malformations.
Inclusion criteria for FT infants are:
- gestational age ≥ 37weeks;
- birth weight ≥ 2,500g;
- APGAR 5' ≥ 7 - delivery without any complications for the child and/or mother;
- no pre/postnatal/postnatal clinical conditions;
- no hospitalizations at the time of birth or postpartum;
- absence of malformative syndromes and/or major malformations.
Inclusion criteria for mothers are:
- mothers of Italian nationality;
- mother over 18 years of age;
- mother with absence of manifest psychiatric and/or cognitive pathologies (must be previously diagnosed major psychiatric pathologies);
- non-addicted/no habitual use of psychotropic medications, drugs, alcohol no smoking;
- non-single-parent families.
Exclusion criteria: refer to inclusion criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04804280
Contact: Rosario Montirosso | +39031877494 | rosario.montirosso@lanostrafamiglia.it |
Italy | |
Associalzione La Nostra Famiglia - IRCCS Eugenio Medea | Recruiting |
Bosisio Parini, Lecco, Italy, 23842 | |
Contact: Rosario Montirosso +39031877494 rosario.montirosso@lanostrafamiglia.it |
Responsible Party: | IRCCS Eugenio Medea |
ClinicalTrials.gov Identifier: | NCT04804280 |
Other Study ID Numbers: |
RC2020_751 |
First Posted: | March 18, 2021 Key Record Dates |
Last Update Posted: | October 18, 2023 |
Last Verified: | October 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
At-risk Infants Developmental Care DNA methylation affectionate touch Insular cortex |
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications |
Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |