Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05977400 · ClinicalTrials.gov registry record · Phase 3
NICU Antibiotics and Outcomes (NANO) Follow-up Study
A Phase 3 study, sponsored by Sharp HealthCare.
- Not yet
- Registry status
- Phase 3
- Development phase
- 802
- Enrollment target
NCT05977400: Clinical Trial Phase 3 study, sponsored by Sharp HealthCare.
NCT05977400 is a Phase 3 study that has not yet begun recruiting, run by Sharp HealthCare. The registered enrollment target is 802 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05977400, a Phase 3 study, has not yet begun recruiting, sponsored by Sharp HealthCare.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 802 participants
- Enrollment target
Study Summary
The NANO follow-up study is designed to determine whether a simple, cost-effective intervention- withholding antibiotics at birth- reduces clinically relevant outcomes such as behavioral and neurological impairment at 2 years of age. This study will be the largest study evaluating the effects of early antibiotics in children with comprehensive measures of neurodevelopment linked to genomic variants and microbiota interactions.
Primary Outcome
The first primary outcome will be a composite of newborn or childhood death OR one of following: cognitive or motor composite scores \<80 on the Bayley-4, Gross Motor Function Classification Score score ≥2, bilateral blindness, severe functional hearing impairment. The incidence of the composite outcome will be compared between the placebo and early antibiotic groups.
Interventions
- DRUG Placebo
- DRUG Gentamicin
- DRUG Ampicillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 802 participants |
| Start Date | 2024-04 |
| Est. Completion | 2029-03 |
| Phase | Phase 3 |
What is known before NCT05977400 opens enrollment
NCT05977400 is an interventional study that assigns participants to a tested intervention. The registered 802 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05977400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05977400 about?
NCT05977400 is a clinical study titled "NICU Antibiotics and Outcomes (NANO) Follow-up Study". The NANO follow-up study is designed to determine whether a simple, cost-effective intervention- withholding antibiotics at birth- reduces clinically relevant outcomes such as behavioral and neurological impairment at 2 years of age. This study will be the largest study evaluating the effects of ear...
What is the current status of trial NCT05977400?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 802 participants. The study started on 2024-04. Estimated completion is 2029-03.
What interventions are being tested in trial NCT05977400?
The interventions under investigation include: Placebo (DRUG), Gentamicin (DRUG), Ampicillin (DRUG).
Who is sponsoring clinical trial NCT05977400?
This trial is sponsored by Sharp HealthCare, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05977400's enrollment target sits among peer trials
802 413th of 2000 higher than 1,587 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03524430 · 801 participants · NA
RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy
- NCT04423211 · 804 participants · Phase 3
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
- NCT06522022 · 804 participants · NA
PTSD Screening in Pregnant Black Women
- NCT00695214 · 800 participants · Phase 2
Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia