The Effect of a Neonatologist's Standardized Guidance Intervention on Preterm Infants With Relational Withdrawal.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03212547
• Date of registration: 07/07/2017
• Prospective Registration: Yes
• Primary sponsor: Clinica Alemana de Santiago
• Public title: The Effect of a Neonatologist's Standardized Guidance Intervention on Preterm Infants With Relational Withdrawal.
• Scientific 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.
• Date of first enrolment: September 19, 2017
• Target sample size: 140
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT03212547
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Chile

Contacts

• Name: Jorge Bustamante Loyola, Phd student
• Affiliation: Clínica Alemana de Santiago

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: 3 Days
Gender: All

Health Condition(s) or Problem(s) studied

Social Withdrawal of Childhood or Adolescence

Preterm Infant

Intervention(s)

Behavioral: Verbal Intervention

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

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]

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]

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]

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]

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]

Secondary ID(s)

ADBB Chile

Source(s) of Monetary Support

Please refer to primary and secondary sponsors