A randomized clinical trial pretest-posttest design was conducted on mother- LBW infant dyads in a gynecology and obstetrics hospital and comprehensive health centers affiliated with Hamadan University of Medical Sciences, Iran, in 2016 (Research number: 9,409,034,759, IRCT20120215009014N421). A Planned lactation education was implemented for the mothers in the experimental group over five training sessions in addition the routine education by one of the researcher; however, the control group (socio-demographically homogenous to the experimental group) received the routine education program. The main parameters concerned in this study included the mothers’ breastfeeding practice, and the LBW infants’ weight gain.
In this study, 80 mothers of LBW and their infants participated. The inclusion criteria for infants were birth weight between 1500 and 2500 g, completed weeks of gestation (more than 37 weeks), exclusive breastfeeding, and lack of diseases, infections, and history of hospital admission due to diseases. The inclusion criteria for mothers were literacy, singleton pregnancy, no prohibition due to disease or medications preventing breastfeeding, no participation in breastfeeding training classes for LBW, and residency in Hamadan City. Mothers changing their residency, becoming sick during the study, or stopping breastfeeding and infants receiving supplementation with formula were also excluded.
After approving the study in the ethics committee, the researchers referred to the gynecology and obstetrics hospital. The researchers explained the study’s objectives to the mothers, and written consent forms were collected from them. The researchers completed the demographic data questionnaire of the parents and their LBW infants. Furthermore, the researchers evaluated the LBW infants’ birth weight and the mother’s breastfeeding practice.
The intervention for the experimental group included routine education and planned lactation training containing five 20-minute face-to-face teaching sessions, with two sessions being held during the mothers’ hospitalization and at discharge time and three sessions being held in the comprehensive health centers at 5, 14–15, and 60 days after the infants’ birth. Furthermore, the mothers received a CD and a written instruction booklet regarding breastfeeding and infant weight gain at the first session.
The training content emphasized the importance of initiating breastfeeding and exclusive breastfeeding for LBW infants, the number and time duration of each breastfeeding per day, the significant skin contact with LBW infants, and significant differences between LBW infants and other infants regarding breastfeeding. Moreover, the mothers were trained regarding correct breastfeeding, i.e., how to hug the baby, provide proper alignment for breastfeeding, make skin-to-skin contact, place the nipple in the baby’s mouth, and spend more time for breastfeeding. The education program also focused on proper weight gain of LBW infants.
After the discharge, all the mother-LBW dyads were followed up in comprehensive healthcare centers, and the researchers controlled weight gain in the infants and answered the mothers’ questions. Furthermore, feedbacks were given to the mothers about weight gain according to the infants’ growth chart. Finally, the infants’ weights were recollected and documented 14–15 days and 60 days after birth; however, the mother’s breastfeeding practice data were recollected 14–15 days after birth.
The control group attended a routine education program, including one 10-minute session held in hospital and two 15-minute sessions held in the comprehensive health centers with a similar educational content provided to mothers in the experimental group, 14–15 days and 60 days after the infants’ birth. However, they did not receive any CDs or written booklets. It is noteworthy that as the number of sessions was greater and the duration of each session was longer in the experimental group compared to the control group, it was possible for the researchers to spend more time answering mothers’ questions, precisely monitor breastfeeding performance, and improve positioning and attachment. As a result, mothers in the experimental group received more careful supervision and more supportive encouragement.
The data were collected using four instruments: Demographic data of the parents, demographic data of the LBW infants, the LBW infants’ weight, and the mothers’ breastfeeding practice.
The parents’ demographic data included mothers’ age, education level of parents, parents’ occupation, family income, and family residency.
The infants’ demographic data were assessed by a questionnaire including gestational age, sex, birth rank, and type of delivery.
The LBW infants’ weight was measured by the researchers according to the guidelines  using a balanced Seca scale. The LBW infants’ weight was measured at birth, 14–15 days, and two months after birth.
The researchers applied the checklist used by Ahmadi et al.  at birth and 14–15 days later to evaluate the mother’s breastfeeding practice. This checklist comprises 17 questions regarding the correct method of breastfeeding (e.g., infant’s body being in line with the mother’s body, infant’s body having close contact with the mother’s body, the majority of the areola being in the infant’s mouth, gentle and deep sucking of the breast by the infant, and no pain on the mother’s nipple while breastfeeding). The researcher observed breastfeeding practice and gave a score of “1” for the correct performance of each item and “0” otherwise. Thus, the minimum and maximum scores ranged from 0 to 17.
The validity of the mother’s breastfeeding practice checklist was confirmed using qualitative content validity. The reliability of the breastfeeding practice checklist was determined by a pilot study carrying out on 20 LBW infants’ mothers. Intra-class coefficients were ≥ 0.92, indicating acceptable reliability. Before each weight measurement time, a standard 500 g weight was used to determine the infant weighing scale’s reliability.
The sample size was estimated to be 37 people for weight gain based on the estimated variance of 3.1 and a minimum significant difference of 2 between the two groups. The sample size was also estimated to be 35 people for breastfeeding practice based on the estimated variance of 5 and a minimum significant difference of 3.3 between the two groups (based on a pilot study). The confidence level of the test and the test power was considered 95% and 80%, respectively. The sample size of each group was enhanced to 43 to increase the power of statistical tests.
In this study, eligible mothers and their LBW infants randomly assigned through the block randomization into two groups with 40 mother-LBW infants dyads in experimental (receiving a planned lactation training and routine education) and control (receiving routine education) groups. For this purpose, researchers prepared four sheets of paper, writing on two sheets the name of the experimental and on the other two sheets the name of the control. The paper sheets were folded, placed in a container, and randomly drawn one at a time for each mother without replacement until all four sheets are drawn. The four paper sheets were then placed back into the container, and this action repeated until the sample size were reached.
The collected data were analyzed at a 95%confidence interval using the Kolmogorov-Smirnov test, paired samples t-test, independent two-sample t-test, and repeated measures ANOVA in SPSS software version 16.