Clinical trial NCT04478162: The Effect of Family Integrated Care on Preparing Parents With Premature Infants Hospitalized in the Neonatal Intensive Care Unit for Discharge
Official title: Investigation of the Effect of Family Integrated Care Method on Preparedness for Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Intensive Care Unit
Parents
Keywords: premature
Family Integrated Care
discharge
readiness
parents
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 68
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Physiological and structural features of premature infants differ from mature newborns. Families worry about touching their very sensitive and fragile babies, which are quite different from their expectations, and they seriously concern about how they will take care of their babies who are cared for by the specialist staff at the hospital when they are discharged to home. Different approaches and models are applied in the Neonatal Intensive Care Units (NICU) to prepare families, especially mothers, for the discharge process and to overcome these fears of the parents. However, most of the time, investigators observe in both researches and units that these approaches are not efficient. In this study, which investigators started with the questions as "What can investigators do better in this issue?" and "How can investigators help families more in this process?", investigator have seen that Family Integrated Care (FICare) model is applied in some clinics abroad and successful results have been obtained. However, investigators did not come across a study that applied this model and examined the effect of it on parents on being ready for discharge. Since this study will be a first in terms of both this aspect and the application of this model in our country, in this unique study, investigators aim to draw attention to this approach in our country, also contribute to keeping the premature babies healthy.

Research Hypotheses:

H0 There is no difference between the readiness for discharge of mothers and fathers included in the FICare model compared to the control group.

H1 The hypothesis of this study is that the mothers included in the FICare model have higher levels of discharge readiness than the control group.

H2 The hypothesis of this study is that the fathers included in the FICare model have higher levels of discharge readiness than the control group.

Detailed description: Background: The Family Integrated Care (FICare) model is a modern approach that supports the participation of parents (excluding ventilation, monitor adjustments, vascular fluid and drug administration) developed in collaboration between parents and healthcare professionals, which is carried out gradually in the NICU (1). Parents are informed about the general development of the baby, brain and sensory development, motor and behavior development, care of the premature. In addition, parents are informed about what they can do about general body cleaning and care, especially in touch, attachment, skin-to-skin contact, breastfeeding and increased breast milk and diaper change (2).FICare; It is a care model with a 25% increase in the weight gain of premature babies, a 80% increase in breastfeeding rate, a 25% decrease in parental stress, a significant decrease in critical incident reports such as hospital infection and sudden infant death (3). The care that these babies receive in their first hours, days, weeks and months is vital to determine their future health and long-term outcomes. Evidence suggests that if parents are supported and encouraged to take care of their babies while in hospital, this will have better outcomes for both the baby and their family. FICare support not only reduces the length of hospital stay of parents, but also reduces the rate of re-hospitalization, and strengthens the bond between parents and babies. It helps parents feel safer when taking care of their babies, both in the hospital and at home (4).

A standard care model for discharge preparation is not applied to parents who have a premature baby in their NICU. Institutions make the decision to discharge with the opinions of the doctor and nurse working in the unit. With the FICare model, it is thought that parents will be prepared for discharge, bonding between parents and babies, fulfilling their parental roles, supporting babies' breastfeeding, reducing hospital stay, enhancing parental-employee communication, and increasing the quality of care services..

Premature infants who were hospitalized for at least seven days between February 6, 2020, and August 15, 2021, in the NICU of a training and research hospital formed the population of the study. In the study, the total number of parents was determined as 68 when the margin of error was 5%, the power level was 81.17%, and the effect size value was 0.70. At the end of the study, a post hoc power analysis was conducted to determine the adequacy of the sample size. As a result of the power analysis, for the details of the difference between the groups in terms of the scale score of fathers with premature babies in the neonatal intensive care unit, type 1 error: 0.05, n: 68 people, effect size = 1.990, and the power level according to the structure was determined as 1.000. To determine the difference in terms of the scale score of mothers with premature babies in the neonatal intensive care unit, type 1 error: 0.05, n: 68 people, effect size = 2.586 and power level according to temperature was determined as 1.000. These values show that the sample size is sufficient.

Eligibility criteria: Inclusion Criteria:

1. Birth of the infant at the 28th-34th weeks of gestation,
2. First parenting experience of the mother and the father,
3. Parents' willingness to participate in the study and being open to communication,
4. Mother having breast milk,
5. Participation of parents in the discharge training program.

Exclusion Criteria:

1. Undergoing a surgical intervention,
2. Death of the baby
3. Transfer of the baby to another hospital,
4. Failure of the parent to complete all phases of the study.

Primary outcomes:
measure: Family Integrated Care model and evaluation of routine care practicesevaluation) will increase the readiness of parents.
timeFrame: up to nine months
Secondary outcomes:
measure: Premature infants weight (kg)
timeFrame: up to nine months
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya Education and Training Hospital
state: Adapazarı
Study officials:
affiliation: Sakarya University
name: Nursan ÇINAR, Proffesor
role: PRINCIPAL_INVESTIGATOR
References: