Clinical trial NCT04619459: The Effect of Kangaroo Mother Care Applied to the Healthy Newborns on Breastfeeding
Official title: The Effect of Kangaroo Mother Care Applied to the Healthy Newborns in the Early Postpartum Period on Breastfeeding: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Kangaroo Mother Care
Breastfeeding, Exclusive
Keywords: Kangaroo Mother Care
Breastfeeding
Postpartum Period
Term Newborn
Midwifery
Lead sponsor: Ahi Evran University Education and Research Hospital
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2020-11-06
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Study
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to determine the effect of kangaroo mother care (KMC) applied to the healthy newborns in the early postpartum period on breastfeeding.

The results of the study are expected to contribute to promoting the practice of KMC in an effort to encourage breastfeeding not only in Turkey's hospitals but also in other developing countries where practices that negatively affect breastfeeding are prevalent.

The hypotheses of the study were determined as: Infants administered KMC start to breastfeed sooner (H1), breastfeed more frequently (H2), breastfeed for longer periods (H3), are more successful at breastfeeding (H4) than infants receiving standard postpartum care (SPC).

Detailed description: Setting: The study was conducted over the period June 1 - August 25, 2016 as randomized controlled experimental research at a Training and Research Hospital in Istanbul, Turkey.

Participants: The participants were 112 healthy mothers and their babies; the women were between the ages 18-42, had delivered normal vaginal birth between gestational weeks 38-40, met the sample inclusion criteria and consented to be a part of the study. Instrumental vaginal deliveries were excluded from this study.

The sample selection criteria were determined as: normal delivery, healthy mother and child, newborn being at term (in the 38th-42nd week), with a birthweight of 2500-4000 gr. The inclusion criteria were determined as: no serious case of asphyxiation in the newborn, an APGAR score of at least 7 at Minute 1 and Minute 5, no health problem in the newborn to prevent it from breastfeeding (e.g., cleft palate, harelip, esophageal atresia).

Sample and randomization: The researcher met with the mothers who fulfilled the selection criteria prior to the birth and briefly informed them of the scope and content of the study, asking them if they wished to participate. At this stage, participation was proposed to 119 mothers. Of these, 112 mothers and their babies were randomized into two groups with 56 in the study group (KMC) and 56 in the control group (SPC). A computerized randomization method was used for implementing the random selection. The newborns that exhibited a health issue following the birth were excluded from the study. In their place, the same randomization method was used until 56 cases were defined. The number of newborns held outside the scope of the study after birth was 5 in the study group and 2 in the control group.

Power analysis was performed using the G\*Power (v3.1.9) program in order to determine the number in the sample. Sample size was determined on the basis of the infants' breastfeeding scores obtained on LATCH. It was foreseen that a unit of difference in LATCH scores between groups would be clinically significant. In a study by Yenal et al., when the LATCH mean score and standard deviation were accepted as a reference for control group data, effect size was calculated as d=0.566. It was calculated that at least 51 individuals would have to be included in the groups, a total of 102, to realize the effect level of α=0.05 at a power of 80%. Taking into consideration possible losses, it was decided that the groups would each comprise at least 56, meaning a total of 112 individuals.

Data collection: The study data were collected in line with the literature using the Data Collection Form developed by researchers. The infants' suckling skills were assessed with the "LATCH Breastfeeding Assessment Tool" developed in 1994 by Jensen et al.

Consent: Permission for conduct of the study was obtained from the hospital and the ethics committee (10840098-604.01.01-E.1108). At the same time, prior to the start of the study, the mothers were informed about the purpose and methodology of the research and the mothers agreeing to participate were asked to sign a written Subject Informed Consent Form.

Data analysis: The NCSS (Number Cruncher Statistical System) 2007 (Kaysville, Utah, USA) program was used in the statistical analysis. In the evaluation of the study data, besides descriptive statistical methods (means, standard deviation, median, frequency and percentages), the Shapiro-Wilk test and box plot graphs were employed in testing normality. The Independent Samples T Test was used to analyze two groups of quantitative data displaying normal distribution such as the newborns' weight, height, head circumference, number of breastfeedings received, mother's age. The Mann-Whitney U test was used in the case of variables not showing normal distribution, such as the newborns' APGAR scores at Minutes 1 and 5, the first interaction of the mother with her infant, the first time of breastfeeding, the number of breastfeedings in the first 3 hours and their duration. The comparison of qualitative data such as the infants' gender, the mother's educational status, the status of being breastfed in the first half-hour and hour was undertaken with Pearson's Chi Square while the Fisher-Freeman-Halton test was used to compare the mothers' eagerness to breastfeed. The results were analyzed at a confidence interval of 95% with significance expressed at a level of p\<0.05.

Eligibility criteria: Inclusion Criteria:

* Healthy mothers
* The women were between the ages 18-42,
* Had delivered normal vaginal birth
* Between gestational weeks 38-40
* Consented to be a part of the study
* Newborn being at term (in the 38th-42nd week), with a birthweight of 2500-4000 gr.
* No serious case of asphyxiation in the newborn,
* APGAR score of at least 7 at Minute 1 and Minute 5,
* No health problem in the newborn to prevent it from breastfeeding

Exclusion Criteria:

* Instrumental vaginal deliveries
* Cesarean deliveries

Primary outcomes:
measure: LATCH Breastfeeding Assessment Tool
timeFrame: It was used in both groups before the first breastfeeding.
measure: LATCH Breastfeeding Assessment Tool
timeFrame: After 24 hours the sucking ability of both groups was evaluated.
Secondary outcomes:
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Sevda Korkut Öksüz
state: Bagbası
Study officials:
affiliation: Ahi Evran University Faculty of Health Sciences
name: Sevda K Öksüz, R.A
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.
citation: Oksuz SK, Inal S. The effect of kangaroo mother care applied to the healthy newborns in the early postpartum period on breastfeeding: A randomized controlled trial. J Pak Med Assoc. 2021 Sep;71(9):2124-2129. doi: 10.47391/JPMA.376.