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Can a Doctor's words help preterm babies connect?

NCT ID NCT03212547

Symptom relief Sponsor: Clinica Alemana de Santiago 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers in Chile are testing whether pediatricians trained to detect and respond to social withdrawal can help late and moderately late preterm infants engage more with their parents. The study enrolls 110 preterm infants born between 32 and 36 weeks and their Spanish-speaking parents. During visits, doctors use the Alarm Distress Baby Scale to spot withdrawal and then guide parents through interactions, repeating the guidance when an infant does not respond positively. The trial measures changes in sustained social withdrawal and also tracks parental depression and post-traumatic stress symptoms.

What this could mean

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

Active substance
A pediatrician's standardized verbal guidance for parents during infant interaction
What this could lead to
If it works, this could give doctors a simple, low-cost way to help preterm infants engage socially and lower their risk of later developmental problems.
What could go wrong
This is a small, single-country study of a behavioural intervention, so results may not apply elsewhere. Social withdrawal can have many causes, and a brief guidance session may not be enough to change long-term outcomes.

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

110 people

The number who actually took part.

Started

Sep 2017

Finished

Mar 2021

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

1 day to 3 days

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: * 32 to 36+6 week preterm chilean newborn. Gestational age assigned by neonatologist at birth. * Spanish speaking parents. * Parents with stable cohabiting and both of them responsible for the care of the infant * Double or single pregnancy (monochorionic or bichorionic). * Born and hospitalized within the first 48 hours of life or with a stay of at least 48 hours at Clínica Alemana de Santiago or at Hospital San José. * Signed informed consent. Exclusion Criteria: * Mother with antecedents or confirmed exposure to cocaine, marihuana or cocaine crack during pregnancy * Neurological disease that impairs the infant's development confirmed at birth. * Major congenital malformations or genetic diseases suspected or confirmed antenatally or at birth. * Perinatal asphyxia: \<3 Apgar score at 1 minute or \< 5 at 5 minutes and/or cord pH \<7.0

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Conditions

The condition(s) this trial relates to.

postpartum depression Premature Birth

As listed by the trial registrant

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

Preterm infant Social withdrawal of childhood or adolescence

Contacts and locations

Locations

  • Clinica Alemana de Santiago

    Santiago, Santiago Metropolitan, 7650568, Chile

  • Hospital San Jose

    Santiago, Santiago Metropolitan, 8380755, Chile

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