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Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study
NA trial testing Maternal glycemic control in Pregnancy Preterm in 86 participants. Completed in 19 November 2021.
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 86 |
| Start date | 8 June 2017 |
| Primary completion | 18 February 2021 |
| Estimated completion | 19 November 2021 |
| Sites | 2 locations across United States |
University of North Carolina, Chapel Hill
Adults 18 to 50, female only, with Pregnancy Preterm or Neonatal Hypoglycemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
C-peptide level (ng/mL) as measure of fetal hyperinsulinemia
| Group | Value | 95% CI |
|---|---|---|
| Neonates Born to Mothers Receiving Intervention | 1.02 | 0.52 – 1.86 |
| Neonates Born to Mothers Receiving Usual Care | 1.09 | 0.61 – 1.65 |
Cortisol level (ug/mL) as measure of fetal immune suppression
| Group | Value | 95% CI |
|---|---|---|
| Neonates Born to Mothers Receiving Intervention | 2.0 | 1.1 – 5.1 |
| Neonates Born to Mothers Receiving Usual Care | 2.5 | 1.7 – 5.9 |
Insulin-like growth factor 1 level (ng/mL) as a measure of in utero metabolic status
| Group | Value | 95% CI |
|---|---|---|
| Neonates Born to Mothers Receiving Intervention | 78 | 53 – 98 |
| Neonates Born to Mothers Receiving Usual Care | 58 | 42 – 90 |
Leptin level (ng/mL) as measure of fetal adiposity
| Group | Value | 95% CI |
|---|---|---|
| Neonates Born to Mothers Receiving Intervention | 7.5 | 4.4 – 11.2 |
| Neonates Born to Mothers Receiving Usual Care | 5.6 | 3.2 – 12.6 |
Number of neonates with capillary blood glucose \< 40 mg/dL
| Group | Value | 95% CI |
|---|---|---|
| Neonates Born to Mothers Receiving Intervention | 20 | |
| Neonates Born to Mothers Receiving Usual Care | 21 |
Number of neonates with hypoglycemia requiring treatment with dextrose gel or dextrose intravenous fluids
| Group | Value | 95% CI |
|---|---|---|
| Neonates Born to Mothers Receiving Intervention | 9 | |
| Neonates Born to Mothers Receiving Usual Care | 8 |
Lowest neonatal capillary blood glucose (mg/dL)
| Group | Value | 95% CI |
|---|---|---|
| Neonates Born to Mothers Receiving Intervention | 42.3 | ± 2.9 |
| Neonates Born to Mothers Receiving Usual Care | 42.2 | ± 2.2 |
Number of hours after birth when lowest neonatal capillary blood glucose was measured
| Group | Value | 95% CI |
|---|---|---|
| Neonates Born to Mothers Receiving Intervention | 1.7 | 1.5 – 4.3 |
| Neonates Born to Mothers Receiving Usual Care | 1.7 | 1.4 – 3.6 |
Number of neonates admitted to the neonatal intensive care unit for \> 24 hours
| Group | Value | 95% CI |
|---|---|---|
| Neonates Born to Mothers Receiving Intervention | 15 | |
| Neonates Born to Mothers Receiving Usual Care | 21 |
Number of days of neonatal intensive care unit stay
| Group | Value | 95% CI |
|---|---|---|
| Neonates Born to Mothers Receiving Intervention | 6 | 4 – 13 |
| Neonates Born to Mothers Receiving Usual Care | 7 | 2 – 11 |
Number of neonates who had seizures
| Group | Value | 95% CI |
|---|---|---|
| Neonates Born to Mothers Receiving Intervention | 0 | |
| Neonates Born to Mothers Receiving Usual Care | 0 |
Number of neonates who died
| Group | Value | 95% CI |
|---|---|---|
| Neonates Born to Mothers Receiving Intervention | 0 | |
| Neonates Born to Mothers Receiving Usual Care | 0 |
Time frame: Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Mothers: Intervention | Mothers: Usual Care | Neonates Born to Mothers R… | Neonates Born to Mothers R… |
|---|---|---|---|---|---|
| Neonatal Hypoglycemia | Endocrine disorders | — | — | — | — |
| Neonatal Intensive Care Unit Admission | General disorders | — | — | — | — |
| Neonatal Hyperbilirubinemia | Hepatobiliary disorders | — | — | — | — |
| Cesarean delivery | Reproductive system and breast disorders | — | — | — | — |
| Neonatal Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Neonatal Apnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Transient Tachypnea of the Newborn | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
Data from ClinicalTrials.gov NCT03076775 adverse events section.
Annually in the U.S 300,000 neonates are born late preterm, defined as 34 weeks 0 days - 36 weeks 6 days. The Antenatal Late Preterm Steroids (ALPS) Trial demonstrated that maternal treatment with betamethasone in the late preterm period significantly reduces neonatal respiratory complications, but also increases neonatal hypoglycemia, compared to placebo. This research study will attempt to answer the following primary question: Does a management protocol aimed at maintaining maternal euglycemia after ALPS decrease fetal hyperinsulinemia, compared to usual antepartum care?
2 peer-reviewed publications reference this trial (live from Europe PMC):
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