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A Community-Wide experiment: can a few nurse visits shield newborns from harm?

NCT ID NCT01406184

Prevention Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This trial tests whether a short program of nurse home visits for all newborns in a community can prevent child maltreatment and improve child well-being. Families are randomly assigned to receive the Durham Connects program or to a control group. The program includes a hospital visit, one to three home visits in the first months of life, and connections to community resources. The study will compare rates of child maltreatment, emergency room visits, and other outcomes between the two groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Durham Connects program: brief nurse home visits for newborns and their families
What this could lead to
If effective, this program could become a model for preventing child maltreatment across entire communities, improving child health and family functioning.
What could go wrong
The trial is early and results may not apply to other communities. The program's success depends on community resources and family engagement, which can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

2,329 people

The number who actually took part.

Started

Jul 2009

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 6 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infant born between July 1, 2009 and December 31, 2010 * Infant born at Durham County, North Carolina (NC) hospital (Duke or Durham Regional) * Family of infant resides in Durham County, NC Exclusion Criteria: * Infant born before July 1, 2009 or after December 31, 2010 * Infant not born at Durham County, NC hospital * Family of infant resides outside of Durham County, NC

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Unspecified child maltreatment, confirmed Unspecified child maltreatment, suspected

Contacts and locations

Locations

  • Center for Child and Family Policy, Duke University

    Durham, North Carolina, 27708, United States

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