Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04761419 |
| Other study ID # |
FCC-cohort1 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
February 2026 |
Study information
| Verified date |
November 2023 |
| Source |
Nagano Children's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
An observational cohort study to show the effect of parents' presence beside their infants,
skin-to-skin contact (SCC), participation in infant care, or any interaction with their
infants on parents' and infants' short- and long-term outcomes. Investigators create a
hypothesis that longer parents' presence, SCC, participation in infant care, and any
interaction with their infants affect outcomes of infants and parents by preventing parents'
depression and promoting parent-infant bonding and, in addition, by shortening the length of
stay, promoting growth, promoting establishment breastfeeding, and improving developmental
outcomes. Parents are asked to make a record of the length of their presence, SCC,
participation in infant care, and any interaction with their infants, which are quantitative
measurements of family centered care (FCC). Investigators also collect the data related to
the background information of the family, delivery, the clinical course of infants, and the
outcome measures of the infants and parents. No intervention is included in this research.
The study setting is a level IV neonatal intensive care unit (NICU) at Nagano Children's
Hospital in Nagano, Japan. Eligible infants are those who are born at 34 weeks of gestation
or earlier from Japanese parents in Nagano Children's Hospital and need admission into NICU
in the same hospital. Infants are excluded from this study if they have any major anomalies
including suspicion of chromosomal disorder on admission, if at least one parent is Not
Japanese, or if they do not survive until discharge home.
The primary outcomes are the EPDS and Japanese version of Mother-to-Infant Bonding Scale
(MIBS-J) of the parents. The secondary outcomes are the followings; (1) length of stay
(days), (2) physical measurements at 36 weeks (g or cm) and growth rate from birth to
discharge home (g or cm /d), (3) breastmilk-feeding (exclusive, partial, or no breast milk)
and the frequency of breastfeeding directly from breast at 36 weeks PMA and at discharge
(average frequency per day), and for the infants whose birth weight <1500g only, (4)
developmental quotient (DQ) at 6 and 18 months of corrected age, and 3 years old assessed by
Kyoto Scale of Psychological Development (KSPD).
Description:
This research protocol was approved by the Ethics Committee of
Nagano Children's Hospital before this research is being conducted. Recruitment is undertaken
by the neonatologists in the unit. They provide written and oral information about the study
when they explain infants' condition to their parents at admission. The parents are given
sufficient time to consider their participation. The informed consent will be asked within 7
days from the birth, otherwise the infant will be excluded from this study. At least one of
the parents should sign the informed consent before enrolment. At the time of agreement,
investigators give the infant an anonymous number to protect personal information.
< Power calculation > The sample size should be decided by the number of parents as the
primary outcomes are for parents. Investigators plan to include 110 couples or families; the
power calculation showed that investigators could detect a 2.5 difference in the mean
Edinburgh Postnatal Depression Scale (EPDS) score of longer and shorter presence groups (with
power 0.8 and alfa 0.05) with this number of parents.
Diary record Parents make a record on daily diary from the
next day of agreement to one day before discharge. Parents make a record about duration of
these four topics; presence, skin-to-skin contact (SCC), participation in infant care, and
any other interaction with their infants.
- "Care taking" includes the followings; breast feeding, bottle feeding, milking, tube
feeding, changing diaper, wiping body, bathing, and any other essential care for baby.
However, any care taking during "SCC" mustn't included in this section.
- "Other interaction with baby" includes the followings; hugging, holding, touching,
watching, talking, reading books, playing, making something or writing diary for baby,
and any other approaches for baby. However, any interaction given during "SCC" or "care
taking" mustn't included in this section.
Investigators use the modified Parent-Infant Closeness Diary. The original diary includes
three items for each mother and father; presence, holding and SCC. Investigators have changed
these items into our own settings as above and changed the used language into Japanese.
Investigators already have got the permission from the developers of this diary. This diary
has one day per page including all the four topics for both parents. Mother and father
respectively draw a line on the blank of specific items they do. They should fill all the
corresponding blanks when they do things for multiple babies. The start and the end times
should be put in 5-minute increments. The validity of Parent-Infant Closeness Diary has
already been proven.
Perinatal Data Collection Perinatal information of the infant includes sex, gestational age,
birth weight, height, head circumference, mode of delivery, parity and plurality of mother,
and Apgar score at 1, 5, and 10 minutes. Investigators will also find out if the infant meets
the criteria for small for gestational age (SGA), which is defined as both birth weight and
height are <10th percentile.
Perinatal information of the family members includes the first meeting days with the infant
and the first SCC days, for mother and father respectively.
Background information of the family includes family composition, presence of mother's
supporter, the number of siblings living with parents, and required time from home to the
hospital.
Background information of the parents includes the age, the educational background, the
smoking history at pregnant, occupation and parental leave, history of depression or any
other mental health problem before and during pregnancy and the history of medication for
that disease, and the degree of social support, which is measured by the Multidimensional
Scale of Perceived Social Support (MSPSS) as mentioned below. These are risk factors of
postpartum depression.
Short version of Multidimensional Scale of Perceived Social Support in Japanese (MSPSS-Js)
The Multidimensional Scale of Perceived Social Support (MSPSS) is widely used self-report
measure of subjectively assessed social support. There have been several modifications for
MSPSS and now it consists of 12 questions with 7-point rating scale ranging from very
strongly disagree (1) to very strongly agree (7) for each question. There is Japanese version
of MSPSS (MSPSS-J), whose reliability and validity have proven. Investigators use short
version of MSPSS-J (MSPSS-Js), which consists of only 7 questions with 7-point rating scale
ranging from 1 to 7 and has high correlation with full version. The total score varies from
minimum 7 to maximum 49, and higher scores indicates to have better social support.
Data Collection of the clinical course The information of the clinical course includes days
of invasive ventilation, days of non-invasive ventilation, days of any respiratory support
including oxygen, the history of patent ductus arteriosus (PDA) operation, the history of
surgical treatment of abdomen, age of full feeding (the amount of enteral nutrition
>=100ml/kg/day), the history and the degree of intraventricular hemorrhage (IVH), and the
history of retinopathy of prematurity (ROP) treatment.
Evaluation at 36 weeks postmenstrual age (PMA) and discharge Investigators measure the weight
(g), height (cm), head circumference(cm), the frequency of breast feeding (per day), and the
type of nutrition (exclusive, partial, or no breast milk) at 36 weeks PMA and when the infant
discharges home or leaves our NICU to another hospital or ward to prepare for discharge.
Investigators also calculate the length of hospital stay (days) and the growth rate of
physical measurements between the time of admission and discharge. If the infant leaves our
NICU before 36 weeks PMA, investigators use the data at that point as an evaluation at 36
weeks PMA.
The Edinburgh Postnatal Depression Scale (EPDS) and Japanese version of Mother-to-Infant
Bonding Scale (MIBS-J) for mother and father All mothers and fathers of the infants enrolled
in this research undergo the Edinburgh Postnatal Depression Scale (EPDS) and Japanese version
of Mother-to-Infant Bonding Scale (MIBS-J) at least twice. Almost all mothers who deliver in
Nagano Children's Hospital usually undergo the EPDS and MIBS-J at 2 and 4 weeks postpartum at
the maternity outpatient clinic. Investigators additionally carry out the EPDS and MIBS-J for
fathers in NICU once within a month postpartum, and for both fathers and mothers at discharge
of their infant for the purpose of this research.
The EPDS is a screening method for mothers to detect postpartum depressive symptoms. It
comprises 10 self-report items, each of which is scored on a four-point scale (0-3). The
total score varies from minimum 0 to maximum 30, and higher scores indicates to have more
depressive symptoms. Investigators use Japanese version of the EPDS, whose reliability and
validity have already proven. The cutoff score for Japanese people to indicate probable major
postpartum depression should be eight and nine, which is lower than that usually used in
western countries.
Mother-to-Infant Bonding Scale (MIBS) is an assessment method for the feelings of a mother
towards her new infant, but investigators use Japanese version of MIBS (MIBS-J), whose
reliability and validity have already proven. MIBS comprises eight self-report items, but
MIBS-J have ten self-report items, each of which is scored on a four-point scale (0-3). The
total score varies from minimum 0 to maximum 30, and higher scores indicate a problematic
bonding between a mother and her infant.
The main risk factors of mothers' postpartum depression are prenatal depression and anxiety,
previous depression or other mental problems, lower income and occupational status,
multiparity, presence of other children, poor marital relationship or without partner, lack
of social support, stressful life events, negative image toward pregnancy, and experiences of
early mother-infant separation. In addition, the risk factors vary depending on when to
evaluate postpartum depression. The depression scores in mothers and fathers of preterm
infants is at its highest just after delivery and will reduce over time, which shows
different change compared with term birth. This is why investigators have to adjust these
confounding factors when investigators evaluate the EPDS and MIBS-J of the parents.
Long-term developmental assessment after discharge (birth weight <1500g) The development of
the infants whose birth weight <1500g are assessed by Kyoto Scale of Psychological
Development (KSPD) at 6 and 18 months of corrected age, and 3 years old at the outpatient
clinic of Nagano Children's Hospital. KSPD is one of the assessment methods to evaluate
developmental quotient and it is known to be well correlated with Bayley III. KSPD consists
of three subscales: Cognitive-Adaptive, Language-Social, and Postural-Motor.
The primary outcomes are the EPDS and Japanese version of Mother-to-Infant Bonding
Scale (MIBS-J) of the parents. Investigators hypothesize that longer parents' presence
decreases the EPDS score and MIBS-J score. Investigators will divide mothers and fathers into
two groups respectively (longer and shorter presence groups) based on the distribution of the
time of parents' presence, and compare the difference of the mean EPDS score and MIBS-J score
between these two groups at each point in time measured.
The secondary outcomes are the followings; (1) length of stay (days), (2) physical
measurements at 36 weeks (g or cm) and growth rate from birth to discharge home (g or cm /d),
(3) breastmilk-feeding (exclusive, partial, or no breast milk) and the frequency of
breastfeeding directly from breast at 36 weeks PMA and at discharge (average frequency per
day), and for the infants whose birth weight <1500g only, (4) developmental quotient (DQ) at
6 and 18 months of corrected age, and 3 years old assessed by KSPD. Investigators hypothesize
that longer parents' presence, SCC, participation in infant care, or any interaction with
infant improve these outcomes. Investigators will divide mothers and fathers into two groups
respectively (longer and shorter presence groups, SCC, participation in infant care, or any
interaction with infant) as mentioned above and compare the difference of these outcomes
between these two groups. In addition, investigators also correct the data from the diary as
the followings; presence of at least one of their parents, SCC with at least one of their
parents, participation of at least one of their parents in infant care, and any interaction
with at least one of their parents, and consider the outcomes in the same manner.
Investigators will also consider (5) the difference of the mean EPDS score and MIBS-J score
between longer and shorter SCC, participation in infant care, or any interaction with infant
groups.
As a statistical analysis, investigators will use a mixed effect model
for the EPDS score and MIBS-J score, a linear regression model for other continuous variables
(length of stay, physical measurements, growth rate, the frequency of breastfeeding and DQ),
and a logistic regression model for binary variable (type of nutrition). Potential
confounders will be adjusted.
