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.
