Not yet recruitingPHASE3INTERVENTIONAL

NICU Antibiotics and Outcomes (NANO) Follow-up Study

The NANO follow-up study wants to learn if very premature babies who received fewer antibiotics shortly after birth have better development later on. It follows babies who were part of an earlier study called the NANO trial. That first study looked at whether giving antibiotics to premature babies in their first three days of life increased serious short-term problems. This new study focuses on their development at 1 and 2 years old, checking things like movement, learning, communication, and behaviour. The aim is to see if holding back antibiotics could be a simple, cost-effective way to improve long-term health for these vulnerable children.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Sharp HealthCare

Enrolment target

802

Start

01 Apr 2024

Estimated completion

01 Mar 2029

Premature Birth Antibiotics Neurodevelopment

What is this study about?

This study, called the NANO follow-up study, is looking at something really important for very premature babies. For a long time, doctors have often given antibiotics to these tiny babies as soon as they're born, just in case they have an infection. While antibiotics can be life-saving, researchers are now wondering if giving them routinely might have unexpected effects on babies' long-term development.

This study will follow up on babies who were part of an earlier trial called the NANO study. That first study included 802 very premature babies born across 13 different hospitals and looked at immediate health issues. Now, the NANO follow-up study wants to see how these children are doing as toddlers. It will specifically check if babies who received fewer antibiotics in their first few days of life show improvements in things like how they move, how they learn and think, how they behave, and how they interact with others.

The findings from this study could be very significant. If it shows that avoiding early antibiotics can lead to better long-term development for premature babies, it could change how doctors care for these vulnerable newborns. The study team will be working closely with families and healthcare professionals to understand what outcomes are most important to them, making sure the research is focused on what truly matters for children's well-being.

Key takeaways

This study investigates if early antibiotic use in premature babies affects their long-term development.
It's a follow-up to a previous study (NANO trial) on very premature infants.
Participation involves developmental assessments at 1 and 2 years of age.
No new medications or treatments are given as part of this follow-up study.
Findings could help improve care for future premature babies.
You can withdraw your child at any time.

Who may be eligible?

To be considered for this follow-up study, your baby must have already been a part of the main NANO study. If your child was in the main NANO study and your family agreed to participate further, they will be eligible for this follow-up part.

The original NANO study looked at newborn babies born between 23 weeks and 30 weeks and 6 days of pregnancy, whose mothers were 18 years or older. These babies had to be born at one of the participating hospitals.

The original study did not include babies who were at very low risk of infection, or those at very high risk (like if the mother had a fever during labour or a specific infection that needed antibiotics). It also excluded babies with major birth defects, those not expected to survive past 72 hours, or those who had already received antibiotics before they could join the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Was my child part of the original NANO study?
Did I agree to participate in the follow-up part of the NANO study?
Was my child born between 23 and 30 weeks of pregnancy?
Was my child born at one of the hospitals involved in the original NANO study?

Answer every question to see your result.

What does participation involve?

If your child was part of the original NANO study and you agree to join this follow-up, here's what it would involve. There will be two main assessment points. The first will be a virtual visit when your child is about 1 year old. During this visit, experts will do some assessments over video to understand your child's movement and general development.

The second, more thorough visit will be in person at around 2 years of age. During this visit, your child will complete several different assessments with trained professionals. These tests will look at their thinking skills, language, movement, social responses, and everyday abilities. They might also include specific checks related to possible autism traits.

Throughout the study, no new medications will be given. This study is purely observational, meaning it's about watching and assessing development rather than providing new treatments. The total participation would cover assessments up to your child's second birthday.

Potential risks and benefits

Participating in this study offers the potential benefit of helping researchers better understand how early antibiotic use affects premature babies' long-term development. This knowledge could lead to better care for future babies. For your child, the benefits would be indirect, potentially contributing to advances in medical practice. The primary risk involves the time commitment required for the assessment visits. There are no known physical risks as no new medications are given. You are free to withdraw your child from the study at any time, for any reason, without it affecting your child's medical care.

Locations (15)

Sharp Mary Birch Hospital for Women & Newborns
Verified postcode
San Diego, United States
Yale University
Verified postcode
New Haven, United States
University of South Florida
Verified postcode
Tampa, United States
University of Louisville
Verified postcode
Louisville, United States
State University of New York Downstate
Verified postcode
Brooklyn, United States
Columbia University
Verified postcode
New York, United States
University of Rochester
Verified postcode
Rochester, United States
Westchester Medical Center
Verified postcode
Valhalla, United States
The Pennsylvania State University
Verified postcode
Hershey, United States
The Children's Hospital of Philadelphia
Verified postcode
Philadelphia, United States
Jefferson Medical College of Thomas Jefferson University
Verified postcode
Philadelphia, United States
Magee-Womens Hospital
Verified postcode
Pittsburgh, United States

Common questions

What is a 'premature' baby?

A premature baby is one born before 37 weeks of pregnancy. This study focuses on very premature babies, born between 23 and 30 weeks.

What is the NANO study?

The NANO study was an earlier research project that looked at whether giving antibiotics to very premature babies soon after birth affected short-term health problems.

Will my child receive any new medication in this study?

No, this is a follow-up study, so your child will not be given any new medications or treatments. It's about observing their development.

What kind of tests will my child have?

The tests will be gentle assessments of their development, looking at things like their movement, how they learn, talk, and interact with the world, appropriate for their age.

How long will my child be involved in the study?

Your child's involvement will include assessments at around 1 year of age (virtual) and 2 years of age (in person).

How to find out more

Anup Katheria, MD

anup.katheria@sharp.com 8589394170 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.