Neonatal HypoglycemiaPhase 4NCT04869709
Late Preterm Corticosteroids and Neonatal Hypoglycemia
A Phase 4 study testing Betamethasone Sodium Phosphate in people with Neonatal Hypoglycemia and Prematurity, run by University of Southern California at 1 site in United States.
Trial summary
This is a prospective randomized controlled trial investigating the timing of betamethasone administration in late preterm infants in relation to delivery and impact on neonatal hypoglycemia. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Hypoglycemia, Prematurity
- What is being tested?
- Betamethasone Sodium Phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2021to Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Singleton pregnancy
- Gestational age 34 0/7 weeks to 36 5/7 weeks
- Planned delivery in late preterm period
Who cannot join
- Prior course of betamethasone during pregnancy
- Twin gestation
- Fetal demise
- Major fetal anomaly
- Maternal contraindication to betamethasone
- Pregestational diabetes
- Expected delivery within 12 hours of randomization
Trial locations and contacts
1 site in 1 country.
Genevieve Mazza contact
United States1 site
LAC+USC Medical Center
Los Angeles, California, 90033
Elizabeth Sasso, elizabeth.sasso@med.usc.edu
Genevieve Mazza, genevieve.mazza@med.usc.edu
About this study
Official title: Timing of Late Preterm Corticosteroid Administration and Neonatal Hypoglycemia
This is a prospective randomized controlled trial investigating the timing of betamethasone administration in late preterm infants in relation to delivery and impact on neonatal hypoglycemia. Previous data has shown that neonatal hypoglycemia is increased in late preterm infants that were exposed to antenatal corticosteroids. The investigators hypothesize that the timing of steroid administration may impact the development of neonatal hypoglycemia.
Read the detailed description
The use of antenatal corticosteroids for women at risk for preterm delivery has become widely adopted as standard of care. The American College of Obstetrics and Gynecologists (ACOG) officially recommends the use of corticosteroids for pregnant women between 24 and 34 weeks of gestation at risk of delivery within 7 days. Since publication of the ALPS trial, the Society of Maternal Fetal Medicine (SMFM) published guidelines supporting the use of late preterm steroids for singleton pregnancies between 34 weeks 0 days and 36 weeks 6 days who are at high risk of preterm birth within 7 days.
A secondary finding of the ALPS trial included the observation that the administration of antenatal betamethasone significantly increased the rate of neonatal hypoglycemia; the authors emphasized that while the long-term risks associated with neonatal hypoglycemia are not fully known, significant hypoglycemia is associated with poor neurodevelopmental outcome.
The optimal interval for administering late preterm steroids before delivery to minimize the risks of hypoglycemia while maximizing the benefits of fetal lung maturity has not been identified. The proposed research study will further investigate this question by randomizing patients to receive late preterm corticosteroids 2 days before delivery versus 7 days before delivery in order to determine if the rates and severity of neonatal hypoglycemia are different.
- Conditions
- Neonatal Hypoglycemia, Prematurity
- Being tested
- Betamethasone Sodium Phosphate
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone Sodium PhosphateDrug
Also called Celestone
Betamethasone Sodium Phosphate 12mg IM q24h for 2 doses
| Study group | Role | What they receive |
|---|---|---|
| Late Preterm Steroids 2 Days | Active comparator | Not described Receives: Drug: Betamethasone Sodium Phosphate |
| Late Preterm Steroids 7 Days | Active comparator | Not described Receives: Drug: Betamethasone Sodium Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Glucose Concentration
Glucose reported in mg/dL; Hypoglycemia defined as concentration < 40 mg/dL
Measured: Delivery to 72 hours of life
Secondary outcomes (11)
Length of Hospital Stay
Days in hospital from date of delivery until date of discharge
Measured: Delivery to discharge from hospital
Use of CPAP or High Flow Nasal Cannula
Drop in oxygen saturation requiring use of CPAP or high flow nasal cannula for at least 12 continuous hours
Measured: Delivery to 72 hours of life
Need for supplemental oxygen
Drop in oxygen saturation requiring use of supplemental oxygen with a fraction of inspired oxygen (FiO2) of at least 0.30 for at least 24 continuous hours
Measured: Delivery to 72 hours of life
Use of ECMO
Drop in oxygen saturation requiring use of ECMO (extracorporeal membrane oxygenation)
Measured: Delivery to 72 hours of life
Use of mechanical ventilation
Drop in oxygen saturation and/or inability to maintain an airway requiring use of mechanical ventilation
Measured: Delivery to 72 hours of life
Stillbirth
Incidence of intrauterine fetal demise at any point after administration of the intervention (betamethasone) and before delivery
Measured: From administration of the intervention (betamethasone) to delivery
Neonatal death
Death of fetus after delivery
Measured: Delivery to 30 days of life
Respiratory distress syndrome (RDS)
Defined as the presence of clinical signs of respiratory distress (ie: tachypnea, retractions, flaring, grunting, cyanosis) with a requirement of supplemental oxygen with a fraction of inspired oxygen of more than 0.21 and a chest radiograph showing hypoaeration and reticulogranular infiltrates
Measured: Delivery to 72 hours of life
Transient Tachypnea of the Newborn
Defined when tachypnea (Respiratory Rate >60 breaths per minute) occurs in the absence of chest radiography or a radiograph that was normal and resolved within 72 hours
Measured: Delivery to 72 hours of life
Need for surfactant administration
Need for administration of exogenous surfactant in the setting of neonatal respiratory distress
Measured: Delivery to 72 hours of life
Neonatal pneumonia
Defined when a combination of clinical, microbiologic, and/or radiographic findings suggest primary pulmonary infection as a cause of respiratory distress, fevers, increasing white blood cell count, need for antibiotics, and/or sepsis.
Measured: Delivery to 72 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study startJul 2021 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neonatal HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Sasso, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869709
- Sponsor's protocol ID
- APP-21-01310
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Practice Bulletin No. 159: Management of Preterm Labor. Obstet Gynecol. 2016 Jan;127(1):e29-e38. doi: 10.1097/AOG.0000000000001265.
PubMed 26695585Liggins GC, Howie RN. A controlled trial of antepartum glucocorticoid treatment for prevention of the respiratory distress syndrome in premature infants. Pediatrics. 1972 Oct;50(4):515-25. No abstract available.
PubMed 4561295Gyamfi-Bannerman C, Thom EA, Blackwell SC, Tita AT, Reddy UM, Saade GR, Rouse DJ, McKenna DS, Clark EA, Thorp JM Jr, Chien EK, Peaceman AM, Gibbs RS, Swamy GK, Norton ME, Casey BM, Caritis SN, Tolosa JE, Sorokin Y, VanDorsten JP, Jain L; NICHD Maternal-Fetal Medicine Units Network. Antenatal Betamethasone for Women at Risk for Late Preterm Delivery. N Engl J Med. 2016 Apr 7;374(14):1311-20. doi: 10.1056/NEJMoa1516783. Epub 2016 Feb 4.
PubMed 26842679Society for Maternal-Fetal Medicine (SMFM) Publications Committee. Implementation of the use of antenatal corticosteroids in the late preterm birth period in women at risk for preterm delivery. Am J Obstet Gynecol. 2016 Aug;215(2):B13-5. doi: 10.1016/j.ajog.2016.03.013. Epub 2016 Mar 15. No abstract available.
PubMed 26992737Kamath-Rayne BD, Rozance PJ, Goldenberg RL, Jobe AH. Antenatal corticosteroids beyond 34 weeks gestation: What do we do now? Am J Obstet Gynecol. 2016 Oct;215(4):423-30. doi: 10.1016/j.ajog.2016.06.023. Epub 2016 Jun 21.
PubMed 27342043Uquillas KR, Lee RH, Sardesai S, Chen E, Ihenacho U, Cortessis VK, Barton L. Neonatal hypoglycemia after initiation of late preterm antenatal corticosteroids. J Perinatol. 2020 Sep;40(9):1339-1348. doi: 10.1038/s41372-020-0589-1. Epub 2020 Feb 14.
PubMed 32060360
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Late Preterm Corticosteroid Administration and Neonatal Hypoglycemia
- ClinicalTrials.gov ID
- NCT04869709
- Acronym / sponsor ID
- APP-21-01310
- Conditions
- Neonatal Hypoglycemia, Prematurity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized controlled trial investigating the timing of betamethasone administration in late preterm infants in relation to delivery and impact on neonatal hypoglycemia. Previous data has shown that neonatal hypoglycemia is increased in late preterm infants that were exposed to antenatal corticosteroids. The investigators hypothesize that the timing of steroid administration may impact the development of neonatal hypoglycemia.
Detailed description
The use of antenatal corticosteroids for women at risk for preterm delivery has become widely adopted as standard of care. The American College of Obstetrics and Gynecologists (ACOG) officially recommends the use of corticosteroids for pregnant women between 24 and 34 weeks of gestation at risk of delivery within 7 days. Since publication of the ALPS trial, the Society of Maternal Fetal Medicine (SMFM) published guidelines supporting the use of late preterm steroids for singleton pregnancies between 34 weeks 0 days and 36 weeks 6 days who are at high risk of preterm birth within 7 days.
A secondary finding of the ALPS trial included the observation that the administration of antenatal betamethasone significantly increased the rate of neonatal hypoglycemia; the authors emphasized that while the long-term risks associated with neonatal hypoglycemia are not fully known, significant hypoglycemia is associated with poor neurodevelopmental outcome.
The optimal interval for administering late preterm steroids before delivery to minimize the risks of hypoglycemia while maximizing the benefits of fetal lung maturity has not been identified. The proposed research study will further investigate this question by randomizing patients to receive late preterm corticosteroids 2 days before delivery versus 7 days before delivery in order to determine if the rates and severity of neonatal hypoglycemia are different.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Late Preterm Steroids 2 Days | Active comparator | Drug: Betamethasone Sodium Phosphate |
| Late Preterm Steroids 7 Days | Active comparator | Drug: Betamethasone Sodium Phosphate |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Singleton pregnancy
- Gestational age 34 0/7 weeks to 36 5/7 weeks
- Planned delivery in late preterm period
Key exclusion criteria (7 listed)
- Prior course of betamethasone during pregnancy
- Twin gestation
- Fetal demise
- Major fetal anomaly
- Maternal contraindication to betamethasone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betamethasone Sodium PhosphateAlso: CelestoneBetamethasone Sodium Phosphate 12mg IM q24h for 2 doses | Drug | Late Preterm Steroids 2 Days, Late Preterm Steroids 7 Days |
Primary outcome
Neonatal Glucose Concentration
Time frame: Delivery to 72 hours of life
Glucose reported in mg/dL; Hypoglycemia defined as concentration < 40 mg/dL
11 secondary outcomes
Length of Hospital Stay
Time frame: Delivery to discharge from hospital
Use of CPAP or High Flow Nasal Cannula
Time frame: Delivery to 72 hours of life
Need for supplemental oxygen
Time frame: Delivery to 72 hours of life
Use of ECMO
Time frame: Delivery to 72 hours of life
Use of mechanical ventilation
Time frame: Delivery to 72 hours of life
Stillbirth
Time frame: From administration of the intervention (betamethasone) to delivery
Neonatal death
Time frame: Delivery to 30 days of life
Respiratory distress syndrome (RDS)
Time frame: Delivery to 72 hours of life
Transient Tachypnea of the Newborn
Time frame: Delivery to 72 hours of life
Need for surfactant administration
Time frame: Delivery to 72 hours of life
Neonatal pneumonia
Time frame: Delivery to 72 hours of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Background: PubMed 26695585Practice Bulletin No. 159: Management of Preterm Labor. Obstet Gynecol. 2016 Jan;127(1):e29-e38. doi: 10.1097/AOG.0000000000001265.
- Background: PubMed 4561295Liggins GC, Howie RN. A controlled trial of antepartum glucocorticoid treatment for prevention of the respiratory distress syndrome in premature infants. Pediatrics. 1972 Oct;50(4):515-25. No abstract available.
- Background: PubMed 26842679Gyamfi-Bannerman C, Thom EA, Blackwell SC, Tita AT, Reddy UM, Saade GR, Rouse DJ, McKenna DS, Clark EA, Thorp JM Jr, Chien EK, Peaceman AM, Gibbs RS, Swamy GK, Norton ME, Casey BM, Caritis SN, Tolosa JE, Sorokin Y, VanDorsten JP, Jain L; NICHD Maternal-Fetal Medicine Units Network. Antenatal Betamethasone for Women at Risk for Late Preterm Delivery. N Engl J Med. 2016 Apr 7;374(14):1311-20. doi: 10.1056/NEJMoa1516783. Epub 2016 Feb 4.
- Background: PubMed 26992737Society for Maternal-Fetal Medicine (SMFM) Publications Committee. Implementation of the use of antenatal corticosteroids in the late preterm birth period in women at risk for preterm delivery. Am J Obstet Gynecol. 2016 Aug;215(2):B13-5. doi: 10.1016/j.ajog.2016.03.013. Epub 2016 Mar 15. No abstract available.
- Background: PubMed 27342043Kamath-Rayne BD, Rozance PJ, Goldenberg RL, Jobe AH. Antenatal corticosteroids beyond 34 weeks gestation: What do we do now? Am J Obstet Gynecol. 2016 Oct;215(4):423-30. doi: 10.1016/j.ajog.2016.06.023. Epub 2016 Jun 21.
- Background: PubMed 32060360Uquillas KR, Lee RH, Sardesai S, Chen E, Ihenacho U, Cortessis VK, Barton L. Neonatal hypoglycemia after initiation of late preterm antenatal corticosteroids. J Perinatol. 2020 Sep;40(9):1339-1348. doi: 10.1038/s41372-020-0589-1. Epub 2020 Feb 14.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Genevieve Mazza contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Betamethasone Sodium Phosphate in people with Neonatal Hypoglycemia and Prematurity, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Sasso (3234093536, elizabeth.sasso@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Glucose Concentration (time frame: Delivery to 72 hours of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04869709, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.