Factors Associated With Infant Circadian Rhythm, Growth, and Temperament

Sponsor

UCSI University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05700136

Collaborator

(none)

216

Enrollment

Locations

25.2

Anticipated Duration (Months)

21.6

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to learn about the role of modifiable factors affecting infant circadian rhythm so that recommendations can be made for better health outcomes for the mother and infant. The main questions it aims to answer are:

What is the association of prenatal and postnatal maternal circadian clock with infant's circadian clock at 3 months?
What is the association of birth outcomes, maternal factors, and environmental factors with infant circadian clock at 3 months?
What is the role of infant circadian clock on infant growth and temperament at 6 months of age?

Participants will complete a set of questionnaires and provide saliva samples during third trimester of pregnancy and at 3 months after birth of infant.

Condition or Disease	Intervention/Treatment	Phase
Circadian Rhythm Sleep Disorder, Jet Lag Type	Behavioral: MOMENT

Detailed Description

Circadian rhythm is the body's internal clock that synchronizes the body's physiological functions according to the 24-hour sleep-wake cycle. An individual establishes a circadian rhythm 3 months after birth, which is a progressive phase that involves regulating hormones such as cortisol and melatonin. According to previous studies, the synchronization of circadian rhythm between mother-infant pairs have been found to be beneficial in the growth and development of the child by regulating a 24-hour sleep-wake cycle. However, circadian disruption may cause excessive maternal cortisol which can be transferred to the fetus through the placenta during pregnancy and cause growth retardation. Growth faltering during infancy is associated with increased risks of morbidity from infections and chronic diseases in later life. Therefore, it is important to study the relationship between maternal circadian rhythm with synchronization of infant circadian rhythm as it may be one of the potential factors which affects the growth and development of the child.

On the other hand, infant temperament is affected by the maternal and infant circadian rhythm and may also be a predictor to mood disorders such as depression and anxiety. A systematic review reported that high cortisol levels during third trimester of pregnancy is associated with higher emotional reactivity and more difficult temperament infants. Other than the biological factors determining infant temperament, maternal psychological wellbeing during and after pregnancy is also an important element. It has been found that elevated maternal stress was associated with negative infant temperament, resulting in decreased sleep quality of the infant. Negative infant temperament may be a predictor to disordered eating behaviors and growth development. As infant temperament is an important factor in determining growth and development, the risk factors to negative temperament should be studied.

This study aims to determine the role of prenatal and postnatal factors with the infant circadian rhythm and its relationship with infant growth and temperament at 6 months. This study also includes the validation of the Chrononutrition Profile Questionnaire (CPQ) among pregnant women. Through the validation of CPQ, future research about chrononutrition behaviors and eating misalignment can be conducted to replace food record. The design of this study is a prospective observational cohort study. Data will be collected during 3rd trimester of pregnancy, whereas follow-up data on birth outcomes will be collected at birth. At 3 months after birth, data on maternal and infant circadian rhythm will be assessed, then data on growth and development will be collected at 6 months after birth. Data collection is elicited through a properly designed and validated questionnaire namely Chrononutrition Profile Questionnaire (CPQ), Harvard Light Exposure Assessment (H-LEA), sun exposure habits, Morningness-Eveningness Questionnaire (MEQ), Positive and Negative Affect Schedule (PANAS), Pittsburgh Sleep Quality Index (PSQI), and Edinburgh Postnatal Depression Scale (EDPS). Meanwhile, anthropometric data such as gestational weight gain and birth outcomes are gathered from clinic record. In addition, data on infant sleep, feeding, behavior, and light exposure will be collected using Brief Infant Sleep Questionnaire (BISQ), infant feeding log, Baby Eating Behavior Questionnaire (BEBQ), Infant Behavior Questionnaire- Revised (IBQ-R), and infant light exposure log sheet. Cortisol levels will be determined using salivary cortisol method where maternal and infant saliva samples are collected at 3 time points: upon awakening, noon (10:00 to 12:00), and evening (19:30 to 21:00). Understanding the potential factors affecting infant circadian rhythm offers new insights in understanding modern lifestyle factors and its association with fetal programming, infant growth, and development.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

216 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prenatal and Postnatal Factors Associated With Infant Circadian Rhythm, Growth, and Temperament

Actual Study Start Date :

Feb 24, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
MOMENT cohort The cohort will be recruited at third trimester of pregnancy and required to fill up questionnaires and complete saliva collection. We will then follow up with the cohort at 3 months after birth to collect follow up data of the mother and infant. Lastly, we will collect growth outcomes of the infant at 6 months.	Behavioral: MOMENT Prenatal and postnatal factors including maternal, environment, and infant circadian rhythm were studied to determine its effect on infant growth and temperament.

Arm

Intervention/Treatment

MOMENT cohort

The cohort will be recruited at third trimester of pregnancy and required to fill up questionnaires and complete saliva collection. We will then follow up with the cohort at 3 months after birth to collect follow up data of the mother and infant. Lastly, we will collect growth outcomes of the infant at 6 months.

Behavioral: MOMENT

Prenatal and postnatal factors including maternal, environment, and infant circadian rhythm were studied to determine its effect on infant growth and temperament.

Outcome Measures

Primary Outcome Measures

Infant growth in height [Birth to 6 months]
Infant growth is determined by measuring the height (in centimeters) and height for age
Infant growth in weight [Birth to 6 months]
Infant growth is determined by measuring the weight (in kiligrams) and weight for age
Infant growth in head circumference [Birth to 6 months]
Infant growth is determined by measuring the head circumference (in centimeters)
Infant temperament [6 months after birth]
Infant temperament is determined by completing the Infant Behavior Questionnaire- Revised version (IBQ-R)

Secondary Outcome Measures

Infant circadian rhythm [3 months after birth]
Infant circadian rhythm is determined by charting the cortisol rhythms that were tested using saliva samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy pregnant women with no comorbidities before or during pregnancy
Malaysian aged 18-39 years old
Literate in English and Malay language
Single pregnancy

Exclusion Criteria:

Physically disabled
Smoke cigarette and drinks alcohol during pregnancy
On steroid medication
Infants with any deformities or congenital diagnosis.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Klinik Kesihatan Segambut	Kuala Lumpur	Malaysia	51200
2	Klinik Kesihatan Metro Prima	Kuala Lumpur	Malaysia	52100
3	Klinik Kesihatan Cheras Makmur	Kuala Lumpur	Malaysia	56000
4	Klinik Kesihatan Kuchai Ent Park	Kuala Lumpur	Malaysia	57100
5	Klinik Kesihatan Salak Selatan	Kuala Lumpur	Malaysia	57100
6	Klinik Kesihatan Pantai Indah	Kuala Lumpur	Malaysia	59000
7	Klinik Kesihatan Putrajaya Presint 11	Putrajaya	Malaysia	62000
8	Klinik Kesihatan Putrajaya Presint 14	Putrajaya	Malaysia	62000
9	Klinik Kesihatan Putrajaya Presint 18	Putrajaya	Malaysia	62000
10	Klinik Kesihatan Putrajaya Presint 9	Putrajaya	Malaysia	62000