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Parenting for mothers of premature infants

Parenting-promoting intervention for mothers of preterm infants: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2skzz8s
Enrollment
Unknown
Registered
2024-05-08
Start date
2022-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Premature

Interventions

This is an experimental study, randomized clinical trial, with 112 participants in total, allocated into two groups. Both the Intervention (IG) and Control (CG) Groups will receive the unit's standard
in the intervention group, it will be submitted to 5 stages: stage 1 will be filling out the binomial biopsychosocial form, for mothers, by the main researcher (15 minutes)
scale 2 will be the application, by a psychologist, of the Maternal Parenting Self-Efficacy Perception scale (PAEPM) for mothers (10 minutes)
step 3 will be the application of Neonatal Behavior Observation (NBO) with video footage of the baby, by the main researcher (10 minutes)
step 4 will be the presentation of the baby footage with feedback (25 minutes) from the anticipatory guidance list of the NBO registration form and registration on the parent form and routine care of
after a period of 4 to 7 days, steps 2 and 3 are repeated. The GC will have 56 participants
the control group will undergo 5 stages: stage 1 will be filling out the binomial biopsychosocial form, for mothers, by the main researcher (15 minutes)
step 2 will be the completion of the PAEPM Scale, for mothers, by a blinded psychologist (10 minutes)
stage 3 will be application of the NBO with video recording of the baby, by the main researcher (10 minutes)
stage 4 will be the presentation of the footage with discussion of routine care in the kangaroo method, by the main researcher (25 minutes)
After a period of 4 to 7 days, steps 2 and 3 are repeated. Randomization: It will take place through an opaque and sealed envelope, which will con

Sponsors

Universidade Federal do Ceará
Lead Sponsor
Maternidade Escola Assis Chateaubriand
Collaborator

Eligibility

Age
28 Weeks to 3 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria for mother and baby; Mother with at least one child admitted to UCINCa; Preterm baby with corrected Capurro gestational age (IgCC) at birth between 28 weeks and 36 weeks and 6 days, both genders; Baby who at the time of the intervention has between 36 weeks and 3 months of IgCC; Clinically hemodynamically stable baby

Exclusion criteria

Exclusion criteria: Mother and baby exclusion criteria; Mother with cognitive limitation or psychiatric disorder that prevents her from participating in the intervention; Baby who is the twin of a study participant

Design outcomes

Primary

MeasureTime frame
During the analysis of the primary outcomes, it is expected to find that the results of the 4 subscales (taking care, eliciting behavior, reading behavior and situational beliefs) and the total scores of the PAEPM Scale are higher in the post-test, that is, of 4 to 7 days after the pre-test. . Exploratory data analysis will consist of descriptive statistical tests, absolute and relative frequencies; measures of standard deviation, central tendency and dispersion. The Paired Samples T Test will be applied to calculate the p-value (biserial correlation of orders) and effect size (Wilcoxon W), of each item of the scales, factors and domains, of the general, control and intervention groups. The ANOVA Test (Analysis of Variance of Repeated Measures), with intra-subject effects (Time; Time x Group) and inter-subject effects (Group) and Post Hoc Tests (to measure the mean difference and p-Tukey), will be used to compare the items, factors and domains of the scales. Repeated measures analysis of covariance will be used, testing models to verify the weight of outcome variables between groups, adjusted for confounding factors such as birth data (gestational age, APGAR and weight), chronological age and corrected age at the time of observation , length of stay at UCINCa.;It is expected that the results of the 4 dimensions (autonomic responses, motor responses, organization of states and responsiveness), measured through the result of the total NBO scores, are higher in the post-test. . Exploratory data analysis will consist of descriptive statistical tests, absolute and relative frequencies; measures of standard deviation, central tendency and dispersion. The Paired Samples T Test will be applied to calculate the p-value (biserial correlation of orders) and effect size (Wilcoxon W), of each item of the scales, factors and domains, of the general, control and intervention groups. The ANOVA Test (Analysis of Variance of Repeated Measures), with intra-subject effects (Time; Time

Secondary

MeasureTime frame
No secondary outcomes are expected.

Countries

Brazil

Contacts

Public ContactAlessandra Férrer Di Moura

Maternidade Escola Assis Chateaubriand

ferrer.alessandra@yahoo.com.br+55-85-33668569

Outcome results

None listed

Source: REBEC (via WHO ICTRP)