Social Withdrawal of Childhood or AdolescenceNCT03212547
The Effect of a Neonatologist's Standardized Guidance Intervention on Preterm Infants With Relational Withdrawal.
A study testing Verbal Intervention in people with Social Withdrawal of Childhood or Adolescence and Preterm Infant, run by Clinica Alemana de Santiago at 2 sites in Chile.
Trial summary
The objective of this project is to determine the effect of the verbal intervention on the decrease in sustained social withdrawal in late and moderately late preterm infants. The intervention will be performed by pediatricians trained in the Alarm Distress Baby Scale (ADBB). Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Social Withdrawal of Childhood or Adolescence, Preterm Infant
- What is being tested?
- Verbal Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesChile
- Study dates
- 19 Sep 2017to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, 7650568
Hospital San Jose
Santiago, Santiago Metropolitan, 8380755
About this study
Official title: The Effect of a Neonatologist's Standardized Guidance Intervention on Late and Moderately Late Preterm Infants With Sustained Social Withdrawal: a Randomized Controlled Trial in Chile.
The objective of this project is to determine the effect of the verbal intervention on the decrease in sustained social withdrawal in late and moderately late preterm infants. The intervention will be performed by pediatricians trained in the Alarm Distress Baby Scale (ADBB). This scale has been applied to term and preterm newborns in multiple international studies, but it has not yet been applied in Chile, nor with moderately late and late preterm infants.
Infants are social beings who are born with innate reciprocal communication skills that can be observed during the two first months after delivery in babies with normal development. These skills include abilities to make and maintain eye contact, to vocalize and to use facial expressions, body and head movements to start interactions. Micro-analytical studies have demonstrated the frequent appearance of short episodes of social withdrawal affecting the infant during mother-baby interactions, whose function is to regulate the interaction flow. This behavior can be perceived when the infant needs to calm down or when is tired, and as a reaction to transitory interaction disturbances. In contrast with these short episodes of social withdrawal, the occurrence of sustained social withdrawal in infants is significantly less and is frequently associated with pathological conditions, such as autism spectrum disorder, child depression, and severe or chronic pain. Additionally, sustained social withdrawal is a symptom of anxiety and post-traumatic stress disorders. Different studies have revealed a prevalence of 11-22% in pre-term infant populations. In addition, the increase in sustained social withdrawal has been related to deviations of the interaction skills, attachment, as well as to relational and behavioral disorders. The increase and chronification of sustained social withdrawal, used as a defensive conduct, imply a risk to the adequate development of an infant's potential and raise the probability of alterations in the development of his psychopathology.
Read the detailed description
Patients and methods: a prospective multicenter (Clínica Alemana de Santiago and Hospital San José) cohort randomized controlled trial. The study will comprise four periods (during hospitalization and at 2, 6 and 12 months of corrected age). An experimental and a control group will be randomized during the MLP newborn neonatal care unit hospitalization. The experimental group will be composed of late and moderately late preterm infants (MLP) born between 32 to 366 weeks of pregnancy, who will be verbally intervened by neonatologists in outpatient well child consultations at 2, 6 and 12 months corrected age, trough a standarized guidance intervention with the aim of potentiating the interaction of the infant with the parents to reduce sustained social withdrawal. Likewise, an analysis of both institutions (Clinica Alemana de Santiago and Hospital San Jose) will be performed to assess the differences between them. The tools that will be applied are the ADBB scale, as dependent variable; the Edinburgh Post-natal Depression Scale to be applied to parents; the Modified Perinatal Post-Traumatic Stress Disorder Questionnaire and the Revised Impact of Events Scale. During the hospitalization of MLP infants, the painful and invasive procedures to which the infant is subjected will be quantified, as well as neonatal pain, hours of skin-to-skin contact, breastfeeding and parental visits. Results relevance and applicability: Efficient early detection and intervention in infants with sustained social withdrawal behavior is essential to prevent problems in their social and emotional development. Assessing sustained social withdrawal using a standardized and simple scale like the ADBB Scale will allow for monitoring the infant and implementing cost-effective interventions that will benefit him, his family and the society. Identifying the risk groups, i.e. with difficulties in the social and emotional development area, will allow us to optimize the follow-up and integral support programs according to the infants' health needs as well as to establish a care standard.
Intervention Experimental group: the intervention consist in verbal interventions on infants (accompanied by their mother/father) who presents sustained social withdrawal detected on the child consultations (at 2, 6 and 12 months of corrected gestational age). The sustained social withdrawal will be assessed by neonatologists certifieds in the assess of Alarm Distress Baby Scale (during the child consultation) and by certifieds external evaluator, by means of a video (8 to 12 minutes of extension) that will be recorder by the neonatologist and assessed by the external evaluator. If the trained neonatologist detect sustained social withdrawal he will perform the verbal intervention during the child consultation. If the neonatologist does not detect sustained social withdrawal during the pediatric check-up, but the certified external evaluator does when assessing the video, the patient will be contacted and will receive treatment within the time limits described (+- 30 days). Also, the verbal intervention is described in a guide for "Promotion of verbal interventions for interaction" , and will be supplemented with a written guideline for parents to promote adequate interaction between parents and infant.
Control group: infants will assist at child consultations (at 2, 6 and 12 months of corrected gestational age) whit non trained neonatologists. These neonatologists will record a video that will be assessed by certifieds external evaluators. Infants in the control group won't receive the verbal intervention. However, they will receive a development stimulation guide adapted of the ministerial guides for the stimulation of development of the Ministry of Health of Chile.
Infants will be randomized while they are hospitalized in the NICU of Clinica Alemana de Santiago or in the NICU of Hospital San Jose. At the time of randomization, it will be defined whether the infant should attend medical check-ups at 2, 6 and 12 months of corrected gestational age with a neonatologists trained in Alarm Distress Baby Scale, or with a physician not trained, who will not perform the treatment.
Additionally, if during the experimental group medical check-ups at 2, 6 or 12 months of CGA, the physician trained in ADBB detects social withdrawal or finds any acute morbidity such as acute respiratory infection, fever, dehydration, hyperemesis, diarrhea, prolonged pain or irritability, or some acute condition that might affect the quality of the baby's interactions, he will perform a second assessment with the ADBB scale within 15 days.
At the end of the clinical trial, all the infants who present sustained social withdrawal in the medical check-up at 12 months of corrected gestational age will be offered free assessment and intervention (3 sessions) by the research team of this study.
- Being tested
- Verbal Intervention
- Keywords
- ADBB, social withdrawal behavior, preterm, posttraumatic stress, postpartum depression, early detection, interactional guidance, synchronization within parent infant interaction
- Medical subject headings
- Premature Birth, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal InterventionBehavioural
Promotion of verbal interventions:
- Detecting whether the infant has social withdrawal.
- The physician will verbally intervene.
- Positive response (+) from the infant, the evaluator will point out this to the parents.
- Negative response (-) from the infant, the evaluator will include the parents in the interaction.
- If he infant establishes positive contact (+) with the parents, he/she will point out this response to them.
- If the infant does not establish positive contact (-)with the parents, repeat step 2.
- If the infant offers a positive response (+) to the second attempt of verbal intervention, the evaluator will point out this response to the parents.
- At the end of each medical check-up, give and explain the "ADBB Intervention Sheet".
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Verbal interventions made on infants (accompanied by their mothers) who presents sustained social withdrawal detected on the child consultations (at 2, 6 and 12 months of corrected gestational age), made by neonatologists certifieds in the assess of Alarm Distress Baby Scale. Theintervention is described in a guide for "Promotion of verbal interventions for interaction" , and will be supplemented with a written guideline for parents. Receives: Behavioral: Verbal Intervention |
| Control group | No intervention | Control group: infants will assist at child consultations (at 2, 6 and 12 months of corrected gestational age) whit non trained neonatologists. However, these group will receive a development stimulation guide adapted of the ministerial guides for the stimulation of development of the Ministry of Health of Chile. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained social withdrawal
Quantitative categorical variable, ordinal. Category according sum of obtained scores (0-4: No withdrawal, 5-9: moderate withdrawal, 10 or more: Severe withdrawal).
Measured: From date of the 2 months of corrected age medical checkup untill the date of the 12 months of corrected age medical checkup
Secondary outcomes (7)
Post-partum depression
Quantitative categorical variable, nominal. Category obtained from scores lower or higher than 12 points in Edinburgh scale ("No risk" and "risk").
Measured: From date of the 2 months of corrected age medical checkup untill the date of the 12 months of corrected age medical checkup
Post-traumatic stress symptoms
Quantitative categorical variable, nominal. Category obtained from scores lower or higher than 19 points in Modified Perinatal Post-traumatic Stress Disorder Questionnaire ("no risk" and "risk").
Category obtained from scores lower or higher than 24 ("clinical concern") in Impact of Event Scale Revised (IES-R).
Measured: From date of the 2 months of corrected age medical checkup untill the date of the 12 months of corrected age medical checkup
Premature infant pain
Quantitative categorical variable, nominal. Categorys obtained from scores between 0 and 5 points (no pain), 6 and 11 points (pain) and 12 or more points (moderate to severe pain) in the "Premature Infant Pain Profile (PIPP)".
Measured: From date of admission to the NICU untill the date of medical discharge from the NICU or date of death from any cause, whichever came first, assessed up to 10 months
Painful invasive procedures
Quantitative variable. Sum of the daily number of painful invasive procedures registered on the medical chart
Measured: From date of admission to the NICU untill the date of medical discharge from the NICU or date of death from any cause, whichever came first, assessed up to 10 months
Parental visiting time
Quantitative variable. Sum of the daily minutes that the parents are visiting their preterm infants on the NICU
Measured: From date of admission to the NICU untill the date of medical discharge from the NICU or date of death from any cause, whichever came first, assessed up to 10 months
Breastfeeding time
Quantitative variable. Sum of the daily minutes that the mothers are breastfeeding their preterm infants on the NICU
Measured: From date of admission to the NICU untill the date of medical discharge from the NICU or date of death from any cause, whichever came first, assessed up to 10 months
Skin to skin contact time
Quantitative variable. Sum of the daily minutes that the parents are in skin to skin contact with their preterm infants on the NICU
Measured: From date of admission to the NICU untill the date of medical discharge from the NICU or date of death from any cause, whichever came first, assessed up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start19 Sep 2017
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social Withdrawal of Childhood or AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Alemana de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Bustamante Loyola, Phd student, Principal investigator, Clínica Alemana de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212547
- Sponsor's protocol ID
- ADBB Chile
- Status last verified
- Sep 2026
- First submitted
- 7 Jul 2017
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bustamante Loyola J, Perez Retamal M, Mendiburo-Seguel A, Guedeney AC, Salinas Gonzalez R, Munoz L, Cox Melane H, Gonzalez Mas JM, Simo Teufel S, Morgues Nudman M. The Impact of an Interactive Guidance Intervention on Sustained Social Withdrawal in Preterm Infants in Chile: Randomized Controlled Trial. Front Pediatr. 2022 Apr 1;10:803932. doi: 10.3389/fped.2022.803932. eCollection 2022.
PubMed 35433551Bustamante Loyola J, Perez Retamal M, Morgues Nudman MI, Maturana A, Salinas Gonzalez R, Cox H, Gonzalez Mas JM, Munoz L, Lopez L, Mendiburo-Seguel A, Simo S, Palau Subiela P, Guedeney A. Interactive Guidance Intervention to Address Sustained Social Withdrawal in Preterm Infants in Chile: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jun 26;9(6):e17943. doi: 10.2196/17943.
PubMed 32589156
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Neonatologist's Standardized Guidance Intervention on Late and Moderately Late Preterm Infants With Sustained Social Withdrawal: a Randomized Controlled Trial in Chile.
- ClinicalTrials.gov ID
- NCT03212547
- Acronym / sponsor ID
- ADBB Chile
- Keywords
- ADBB, social withdrawal behavior, preterm, posttraumatic stress, postpartum depression, early detection, interactional guidance, synchronization within parent infant interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Clinica Alemana de SantiagoUniversity, hospital or other
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this project is to determine the effect of the verbal intervention on the decrease in sustained social withdrawal in late and moderately late preterm infants. The intervention will be performed by pediatricians trained in the Alarm Distress Baby Scale (ADBB). This scale has been applied to term and preterm newborns in multiple international studies, but it has not yet been applied in Chile, nor with moderately late and late preterm infants.
Infants are social beings who are born with innate reciprocal communication skills that can be observed during the two first months after delivery in babies with normal development. These skills include abilities to make and maintain eye contact, to vocalize and to use facial expressions, body and head movements to start interactions. Micro-analytical studies have demonstrated the frequent appearance of short episodes of social withdrawal affecting the infant during mother-baby interactions, whose function is to regulate the interaction flow. This behavior can be perceived when the infant needs to calm down or when is tired, and as a reaction to transitory interaction disturbances. In contrast with these short episodes of social withdrawal, the occurrence of sustained social withdrawal in infants is significantly less and is frequently associated with pathological conditions, such as autism spectrum disorder, child depression, and severe or chronic pain. Additionally, sustained social withdrawal is a symptom of anxiety and post-traumatic stress disorders. Different studies have revealed a prevalence of 11-22% in pre-term infant populations. In addition, the increase in sustained social withdrawal has been related to deviations of the interaction skills, attachment, as well as to relational and behavioral disorders. The increase and chronification of sustained social withdrawal, used as a defensive conduct, imply a risk to the adequate development of an infant's potential and raise the probability of alterations in the development of his psychopathology.
Detailed description
Patients and methods: a prospective multicenter (Clínica Alemana de Santiago and Hospital San José) cohort randomized controlled trial. The study will comprise four periods (during hospitalization and at 2, 6 and 12 months of corrected age). An experimental and a control group will be randomized during the MLP newborn neonatal care unit hospitalization. The experimental group will be composed of late and moderately late preterm infants (MLP) born between 32 to 366 weeks of pregnancy, who will be verbally intervened by neonatologists in outpatient well child consultations at 2, 6 and 12 months corrected age, trough a standarized guidance intervention with the aim of potentiating the interaction of the infant with the parents to reduce sustained social withdrawal. Likewise, an analysis of both institutions (Clinica Alemana de Santiago and Hospital San Jose) will be performed to assess the differences between them. The tools that will be applied are the ADBB scale, as dependent variable; the Edinburgh Post-natal Depression Scale to be applied to parents; the Modified Perinatal Post-Traumatic Stress Disorder Questionnaire and the Revised Impact of Events Scale. During the hospitalization of MLP infants, the painful and invasive procedures to which the infant is subjected will be quantified, as well as neonatal pain, hours of skin-to-skin contact, breastfeeding and parental visits. Results relevance and applicability: Efficient early detection and intervention in infants with sustained social withdrawal behavior is essential to prevent problems in their social and emotional development. Assessing sustained social withdrawal using a standardized and simple scale like the ADBB Scale will allow for monitoring the infant and implementing cost-effective interventions that will benefit him, his family and the society. Identifying the risk groups, i.e. with difficulties in the social and emotional development area, will allow us to optimize the follow-up and integral support programs according to the infants' health needs as well as to establish a care standard.
Intervention Experimental group: the intervention consist in verbal interventions on infants (accompanied by their mother/father) who presents sustained social withdrawal detected on the child consultations (at 2, 6 and 12 months of corrected gestational age). The sustained social withdrawal will be assessed by neonatologists certifieds in the assess of Alarm Distress Baby Scale (during the child consultation) and by certifieds external evaluator, by means of a video (8 to 12 minutes of extension) that will be recorder by the neonatologist and assessed by the external evaluator. If the trained neonatologist detect sustained social withdrawal he will perform the verbal intervention during the child consultation. If the neonatologist does not detect sustained social withdrawal during the pediatric check-up, but the certified external evaluator does when assessing the video, the patient will be contacted and will receive treatment within the time limits described (+- 30 days). Also, the verbal intervention is described in a guide for "Promotion of verbal interventions for interaction" , and will be supplemented with a written guideline for parents to promote adequate interaction between parents and infant.
Control group: infants will assist at child consultations (at 2, 6 and 12 months of corrected gestational age) whit non trained neonatologists. These neonatologists will record a video that will be assessed by certifieds external evaluators. Infants in the control group won't receive the verbal intervention. However, they will receive a development stimulation guide adapted of the ministerial guides for the stimulation of development of the Ministry of Health of Chile.
Infants will be randomized while they are hospitalized in the NICU of Clinica Alemana de Santiago or in the NICU of Hospital San Jose. At the time of randomization, it will be defined whether the infant should attend medical check-ups at 2, 6 and 12 months of corrected gestational age with a neonatologists trained in Alarm Distress Baby Scale, or with a physician not trained, who will not perform the treatment.
Additionally, if during the experimental group medical check-ups at 2, 6 or 12 months of CGA, the physician trained in ADBB detects social withdrawal or finds any acute morbidity such as acute respiratory infection, fever, dehydration, hyperemesis, diarrhea, prolonged pain or irritability, or some acute condition that might affect the quality of the baby's interactions, he will perform a second assessment with the ADBB scale within 15 days.
At the end of the clinical trial, all the infants who present sustained social withdrawal in the medical check-up at 12 months of corrected gestational age will be offered free assessment and intervention (3 sessions) by the research team of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Verbal InterventionVerbal interventions made on infants (accompanied by their mothers) who presents sustained social withdrawal detected on the child consultations (at 2, 6 and 12 months of corrected gestational age), made by neonatologists certifieds in the assess of Alarm Distress Baby Scale. Theintervention is described in a guide for "Promotion of verbal interventions for interaction" , and will be supplemented with a written guideline for parents. |
| Control group | No intervention | –Control group: infants will assist at child consultations (at 2, 6 and 12 months of corrected gestational age) whit non trained neonatologists. However, these group will receive a development stimulation guide adapted of the ministerial guides for the stimulation of development of the Ministry of Health of Chile. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verbal InterventionPromotion of verbal interventions: 1. Detecting whether the infant has social withdrawal. 2. The physician will verbally intervene. 3. Positive response (+) from the infant, the evaluator will point out this to the parents. 4. Negative response (-) from the infant, the evaluator will include the parents in the interaction. 5. If he infant establishes positive contact (+) with the parents, he/she will point out this response to them. 6. If the infant does not establish positive contact (-)with the parents, repeat step 2. 7. If the infant offers a positive response (+) to the second attempt of verbal intervention, the evaluator will point out this response to the parents. 8. At the end of each medical check-up, give and explain the "ADBB Intervention Sheet". | Behavioural | Experimental group |
Primary outcome
Sustained social withdrawal
Time frame: From date of the 2 months of corrected age medical checkup untill the date of the 12 months of corrected age medical checkup
Quantitative categorical variable, ordinal. Category according sum of obtained scores (0-4: No withdrawal, 5-9: moderate withdrawal, 10 or more: Severe withdrawal).
7 secondary outcomes
Post-partum depression
Time frame: From date of the 2 months of corrected age medical checkup untill the date of the 12 months of corrected age medical checkup
Post-traumatic stress symptoms
Time frame: From date of the 2 months of corrected age medical checkup untill the date of the 12 months of corrected age medical checkup
Premature infant pain
Time frame: From date of admission to the NICU untill the date of medical discharge from the NICU or date of death from any cause, whichever came first, assessed up to 10 months
Painful invasive procedures
Time frame: From date of admission to the NICU untill the date of medical discharge from the NICU or date of death from any cause, whichever came first, assessed up to 10 months
Parental visiting time
Time frame: From date of admission to the NICU untill the date of medical discharge from the NICU or date of death from any cause, whichever came first, assessed up to 10 months
Breastfeeding time
Time frame: From date of admission to the NICU untill the date of medical discharge from the NICU or date of death from any cause, whichever came first, assessed up to 10 months
Skin to skin contact time
Time frame: From date of admission to the NICU untill the date of medical discharge from the NICU or date of death from any cause, whichever came first, assessed up to 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Derived from this study: PubMed 35433551Bustamante Loyola J, Perez Retamal M, Mendiburo-Seguel A, Guedeney AC, Salinas Gonzalez R, Munoz L, Cox Melane H, Gonzalez Mas JM, Simo Teufel S, Morgues Nudman M. The Impact of an Interactive Guidance Intervention on Sustained Social Withdrawal in Preterm Infants in Chile: Randomized Controlled Trial. Front Pediatr. 2022 Apr 1;10:803932. doi: 10.3389/fped.2022.803932. eCollection 2022.
- Derived from this study: PubMed 32589156Bustamante Loyola J, Perez Retamal M, Morgues Nudman MI, Maturana A, Salinas Gonzalez R, Cox H, Gonzalez Mas JM, Munoz L, Lopez L, Mendiburo-Seguel A, Simo S, Palau Subiela P, Guedeney A. Interactive Guidance Intervention to Address Sustained Social Withdrawal in Preterm Infants in Chile: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jun 26;9(6):e17943. doi: 10.2196/17943.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Bustamante Loyola, Phd student principal investigator
Clínica Alemana de Santiago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal Intervention in people with Social Withdrawal of Childhood or Adolescence and Preterm Infant, run by Clinica Alemana de Santiago at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained social withdrawal (time frame: From date of the 2 months of corrected age medical checkup untill the date of the 12 months of corrected age medical checkup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03212547, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.