Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04875624
Other study ID # 2021-13030
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 14, 2021
Est. completion date August 2024

Study information

Verified date February 2024
Source Montefiore Medical Center
Contact Thomas Havranek, MD
Phone 718-904-4105
Email thavrane@montefiore.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators propose to prospectively conduct a neurodevelopmental evaluation of SGA and late preterm neonates who underwent risk-based screening for hypoglycemia at newborn nursery during the first 24 hours of life based on AAP (American Academy of Pediatrics) hypoglycemia guidelines at 18 to 24 months of age. As per internal neonatal unit protocol (reflecting AAP guidelines), all neonates at risk of hypoglycemia (all preterm infants, term infants who are SGA or LGA and IDM) are routinely screened for hypoglycemia during the first 24 hours of life via bedside point of care glucose devices (see attached Weiler NICU (neonatal intensive care unit) hypoglycemia screening protocol). The investigators will compare neurodevelopmental outcomes of those who were and were not hypoglycemic in the newborn nursery based on electronic health record data.


Description:

Neonatal hypoglycemia is the most common metabolic problem in neonates and a preventable cause of brain injury in infancy. Key risk factors for neonatal hypoglycemia include being born preterm, small for gestational age (SGA), large for gestational age (LGA), and being an infant of a diabetic mother (IDM) (1). Approximately 30% of all neonates are considered at risk, of whom approximately 50% develop hypoglycemia (2). Neonatal hypoglycemia is tightly related to adverse neurodevelopmental and brain injury outcomes, particularly among preterm infants who are SGA (3). Screening is recommended for babies with known risk factors (4). Glucose is an essential molecule that supplies energy for brain consumption. Neurons and glial cells in the brain are sensitive to hypoglycemia. Neonatal hypoglycemia has been recognized as a cause of long-term severe neurologic and neurodevelopmental morbidity due to damage to these cells (5). Neonatal hypoglycemia is a common finding associated with brain injury, neurodevelopmental delay, visual impairment, and behavioral problems. Management of hypoglycemia in the newborn period is highly variable among institutions, and recommendations from different professional societies vary. In 2011, the American Academy of Pediatrics (AAP) Committee on Fetus and Newborn published a clinical report suggesting management guidelines for late-preterm and term infants with associated risk factors, targeting infants of IDM, LGA and SGA neonates (2). Of note, AAP clinical report provides guidelines only for the initial 24 hours of life and recommends screening of IDM and LGA infants for 12 hours and screening of SGA and late preterm infants for 24 hours. Canadian Paediatric Society in their updated position statement recommends a similar screening algorithm based on risk factors, stressing the importance of adequate feeding in SGA and late preterm infants. The Pediatric Endocrine Society (PES) issued the recommendations for evaluation and management of persistent hypoglycemia in neonates, infants and children beyond the initial 24 hours of life. The 2011 AAP guidelines define neonatal hypoglycemia as blood glucose <47 mg/dL and recommend maintaining blood glucose >40 mg/dL in the first 4 hours and >45 mg/dl between hours 4-24 (6). The PES has an even stricter threshold of >50 mg/dL. The AAP guidance, however, applies only to the first 24 hours of life, and the PES strategy focuses on infants beyond 48 hours of life with persistent hypoglycemia (7). Due to poor correlation between blood glucose concentrations, clinical manifestations and controversial treatment thresholds, it is difficult to define a safe blood glucose level. Several studies have analyzed the effects of various ranges of hypoglycemia on neurodevelopmental outcome. However, variable results regarding the effect of hypoglycemia on the neurodevelopmental outcome have been reported without any clear conclusion (5,8-12). In this study investigators propose to prospectively conduct a neurodevelopmental evaluation of SGA and late preterm neonates who underwent risk-based screening for hypoglycemia at newborn nursery during the first 24 hours of life based on AAP hypoglycemia guidelines at 18 to 24 months of age. As per neonatal unit protocol (reflecting AAP guidelines), all neonates at risk of hypoglycemia (all preterm infants, term infants who are SGA or LGA and IDM) are routinely screened for hypoglycemia during the first 24 hours of life via bedside point of care glucose devices (see attached Weiler NICU hypoglycemia screening protocol). Aims: 1. To compare cognitive and motor development assessed with the Bayley-4 scoring system between the normoglycemic and hypoglycemic at-risk SGA/late preterm neonates 2. To assess language development, social-emotional and adaptive behavior in the normoglycemic and hypoglycemic at-risk neonates 3. To compare Bayley-4 scores between the cohort of neonates needing intravenous (IV) dextrose administration/neonatal intensive care admission to those with hypoglycemia managed in the newborn nursery as well as to those neonates who remained normoglycemic Hypothesis: The investigators hypothesize that SGA and late preterm hypoglycemic neonates admitted to newborn nursery will have inferior neurodevelopmental outcome at 18 to 24 months age when compared to SGA and late preterm infants with normoglycemia.


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Months to 24 Months
Eligibility Inclusion Criteria: - Born at 35 weeks or more of gestation - Birth weight of 2000 g or more - Indication for routine screening for hypoglycemia: late preterm infants (gestational age from 35 weeks 0 days to 36 weeks 6 days) and newborns who were SGA (birth weight below the 10th percentile on the 2013 Fenton curve). Exclusion Criteria: - Neonates with indication for hypoglycemia screening - screening not properly done or missing - Unable to reach the subject for neurodevelopmental assessment - Non-English speaking subjects

Study Design


Intervention

Diagnostic Test:
Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)
Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) will be administered by one of the 2 blinded examiners who are unaware of neonatal glycemia status. Bayley-4 examines Cognitive, Language, Motor, Social-Emotional and Adaptive Behavior domains of development and may require up to 120 minutes to complete.

Locations

Country Name City State
United States Montefiore Medical Center, Weiler Hospital Bronx New York

Sponsors (1)

Lead Sponsor Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of cognitive development using Bayley-4 scoring system Compare cognitive development assessed with the Bayley-4 scoring system between the normoglycemic and hypoglycemic at-risk SGA/late preterm neonates 120 minutes
Primary Comparison of motor development using Bayley-4 scoring system Assess motor development between the normoglycemic and hypoglycemic at-risk neonates 120 minutes
Secondary Comparison of language development using Bayley-4 scoring system Compare language development using Bayley-4 scoring system between the normoglycemic and hypoglycemic at-risk neonates 120 minutes
Secondary Comparison of social-emotional behavior using Bayley-4 scoring system Comparison of social-emotional behavior using Bayley-4 scoring system between the normoglycemic and hypoglycemic at-risk neonates 120 minutes
Secondary Comparison of adaptive behavior using Bayley-4 scoring system Comparison of adaptive behavior using Bayley-4 scoring system between the normoglycemic and hypoglycemic at-risk neonates 120 minutes
See also
  Status Clinical Trial Phase
Completed NCT03148782 - Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase N/A
Active, not recruiting NCT04935593 - Strengthening Social, Emotional and Behavioral Resilience N/A
Recruiting NCT03222375 - SQUEDâ„¢ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism N/A
Completed NCT04313283 - Translating Peer-to-Peer Support Into a Clinical Setting N/A
Completed NCT04562935 - Long-term Consequences of Admission for Pediatric Intensive Care Before One Year of Age
Not yet recruiting NCT05815095 - Early Detection and Referral for Autism and Neurodevelopmental Disorders at the Maternal and Child Protection Services
Recruiting NCT05017363 - Evaluation of the Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach) N/A
Completed NCT06251830 - Increasing Diagnosis Rates While Reducing Examination Time: Can MR Fingerprinting Deliver on Its Promise?
Completed NCT06052878 - Neurodevelopmental Outcome After Prenatal Anesthesia
Recruiting NCT06012903 - Lower Urinary Tract Symptoms and School Functioning in Children
Not yet recruiting NCT05490173 - The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight Infants N/A
Not yet recruiting NCT06081348 - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders Phase 2
Not yet recruiting NCT05564871 - Effectiveness of Occupational Therapy Teleintervention in Pediatric N/A
Enrolling by invitation NCT02871674 - Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial N/A
Completed NCT01922791 - Nutrition and Pregnancy Intervention Study N/A
Active, not recruiting NCT05428657 - EC Brain Program for Children With Special Education Needs N/A
Recruiting NCT06111898 - Neuro-biomechanical Determinants for Motor Behavior in High-risk Infants
Recruiting NCT05658965 - KIDSHEART AND BRAIN : Early EEG Surgery Congenital Heart Disease Predict Onset of Neurodevelopmental Disorders
Recruiting NCT06086951 - Pai.ACT - An Artificial Intelligence Driven Chatbot Assisted ACT N/A
Recruiting NCT06057441 - Auditory and Visual Noise as Possible Non-pharmacological Treatment of ADHD in School Children N/A